Clinical Trials Register

Summary
EudraCT Number:	2011-005055-14
Sponsor's Protocol Code Number:	P7977-1231
National Competent Authority:	Italy - Italian Medicines Agency
Clinical Trial Type:	EEA CTA
Trial Status:	Completed
Date on which this record was first entered in the EudraCT database:	2012-03-12
Trial results	View results

Index
A. PROTOCOL INFORMATION
B. SPONSOR INFORMATION
C. APPLICANT IDENTIFICATION
D. IMP IDENTIFICATION
D.8 INFORMATION ON PLACEBO
E. GENERAL INFORMATION ON THE TRIAL
F. POPULATION OF TRIAL SUBJECTS
G. INVESTIGATOR NETWORKS TO BE INVOLVED IN THE TRIAL
N. REVIEW BY THE COMPETENT AUTHORITY OR ETHICS COMMITTEE IN THE COUNTRY CONCERNED
P. END OF TRIAL

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A. Protocol Information

A.1

Member State Concerned

Italy - Italian Medicines Agency

A.2

EudraCT number

2011-005055-14

A.3

Full title of the trial

A Phase 3, Multicenter, Randomized, Active-Controlled Study to Investigate the Safety and Efficacy of PSI-7977 and Ribavirin for 12 Weeks Compared to Pegylated Interferon and Ribavirin for 24 Weeks in Treatment-Naïve Patients with Chronic Genotype 2 or 3 HCV Infection.

Studio di fase 3, multicentrico, randomizzato, con controllo attivo per valutare la sicurezza e l'™efficacia di PSI-7977 e ribavirina per 12 settimane in confronto a interferone pegilato e ribavirina per 24 settimane in pazienti naìve al trattamento affetti da infezione cronica da HCV con genotipo 2 o 3.

A.3.1

Title of the trial for lay people, in easily understood, i.e. non-technical, language

An international study to assess the safety and efficacy of new investigational drugs and standard of care in patients with chronic hepatatis C virus infection.

Uno studio internazionale per valutare la sicurezza e l'efficacia di nuovi farmaci sperimentali e della terapia standard nei pazienti affetti da infezione cronica da virus C dell'epatite.

A.3.2

Name or abbreviated title of the trial where available

FISSION

A.4.1

Sponsor's protocol code number

P7977-1231

A.7

Trial is part of a Paediatric Investigation Plan

A.8

EMA Decision number of Paediatric Investigation Plan

B. Sponsor Information
B.Sponsor: 1
B.1.1	Name of Sponsor	GILEAD SCIENCE INC.
B.1.3.4	Country	United States
B.3.1 and B.3.2	Status of the sponsor	Commercial
B.4 Source(s) of Monetary or Material Support for the clinical trial:
B.4.1	Name of organisation providing support	Gilead Sciences Inc.
B.4.2	Country	United States
B.5 Contact point designated by the sponsor for further information on the trial
B.5.1	Name of organisation	Gilead Sciences Inc.
B.5.2	Functional name of contact point	Medical Monitor
B.5.3	Address:
B.5.3.1	Street Address	333 Lakeside Drive
B.5.3.2	Town/ city	Foster City
B.5.3.3	Post code	94404 CA
B.5.3.4	Country	United States
B.5.4	Telephone number	+1 650 574 -3000
B.5.5	Fax number	+1 650 578-9264
B.5.6	E-mail	clinical.trials@gilead.com

D. IMP Identification
D.IMP: 1
D.1.2 and D.1.3	IMP Role	Test
D.2	Status of the IMP to be used in the clinical trial
D.2.1	IMP to be used in the trial has a marketing authorisation	No
D.2.5	The IMP has been designated in this indication as an orphan drug in the Community	No
D.2.5.1	Orphan drug designation number
D.3 Description of the IMP
D.3.1	Product name	NA
D.3.2	Product code	PSI-7977
D.3.4	Pharmaceutical form	Tablet
D.3.4.1	Specific paediatric formulation	No
D.3.7	Routes of administration for this IMP	Oral use
D.3.8 to D.3.10 IMP Identification Details (Active Substances)
D.3.8	INN - Proposed INN	NA
D.3.9.1	CAS number	1190307-88-0
D.3.9.2	Current sponsor code	PSI-7977
D.3.9.3	Other descriptive name	NA
D.3.9.4	EV Substance Code	NA
D.3.10	Strength
D.3.10.1	Concentration unit	mg milligram(s)
D.3.10.2	Concentration type	equal
D.3.10.3	Concentration number	200
D.3.11 The IMP contains an:
D.3.11.1	Active substance of chemical origin	Yes
D.3.11.2	Active substance of biological/ biotechnological origin (other than Advanced Therapy IMP (ATIMP)	No
	The IMP is a:
D.3.11.3	Advanced Therapy IMP (ATIMP)	No
D.3.11.3.1	Somatic cell therapy medicinal product	No
D.3.11.3.2	Gene therapy medical product	No
D.3.11.3.3	Tissue Engineered Product	No
D.3.11.3.4	Combination ATIMP (i.e. one involving a medical device)	No
D.3.11.3.5	Committee on Advanced therapies (CAT) has issued a classification for this product	No
D.3.11.4	Combination product that includes a device, but does not involve an Advanced Therapy	No
D.3.11.5	Radiopharmaceutical medicinal product	No
D.3.11.6	Immunological medicinal product (such as vaccine, allergen, immune serum)	No
D.3.11.7	Plasma derived medicinal product	No
D.3.11.8	Extractive medicinal product	No
D.3.11.9	Recombinant medicinal product	No
D.3.11.10	Medicinal product containing genetically modified organisms	No
D.3.11.11	Herbal medicinal product	No
D.3.11.12	Homeopathic medicinal product	No
D.3.11.13	Another type of medicinal product	No
D.IMP: 2
D.1.2 and D.1.3	IMP Role	Test
D.2	Status of the IMP to be used in the clinical trial
D.2.1	IMP to be used in the trial has a marketing authorisation	Yes
D.2.1.1.1	Trade name	Ribasphere Tablets
D.2.1.1.2	Name of the Marketing Authorisation holder	Three Rivers Pharmaceuticals LLC
D.2.1.2	Country which granted the Marketing Authorisation	United States
D.2.5	The IMP has been designated in this indication as an orphan drug in the Community	No
D.2.5.1	Orphan drug designation number
D.3 Description of the IMP
D.3.4	Pharmaceutical form	Tablet
D.3.4.1	Specific paediatric formulation	No
D.3.7	Routes of administration for this IMP	Oral use
D.3.8 to D.3.10 IMP Identification Details (Active Substances)
D.3.8	INN - Proposed INN	RIBAVIRIN
D.3.9.1	CAS number	36791-04-5
D.3.9.2	Current sponsor code	NA
D.3.9.3	Other descriptive name	NA
D.3.9.4	EV Substance Code	SUB10297MIG
D.3.10	Strength
D.3.10.1	Concentration unit	mg milligram(s)
D.3.10.2	Concentration type	equal
D.3.10.3	Concentration number	200
D.3.11 The IMP contains an:
D.3.11.1	Active substance of chemical origin	Yes
D.3.11.2	Active substance of biological/ biotechnological origin (other than Advanced Therapy IMP (ATIMP)	No
	The IMP is a:
D.3.11.3	Advanced Therapy IMP (ATIMP)	No
D.3.11.3.1	Somatic cell therapy medicinal product	No
D.3.11.3.2	Gene therapy medical product	No
D.3.11.3.3	Tissue Engineered Product	No
D.3.11.3.4	Combination ATIMP (i.e. one involving a medical device)	No
D.3.11.3.5	Committee on Advanced therapies (CAT) has issued a classification for this product	No
D.3.11.4	Combination product that includes a device, but does not involve an Advanced Therapy	No
D.3.11.5	Radiopharmaceutical medicinal product	No
D.3.11.6	Immunological medicinal product (such as vaccine, allergen, immune serum)	No
D.3.11.7	Plasma derived medicinal product	No
D.3.11.8	Extractive medicinal product	No
D.3.11.9	Recombinant medicinal product	No
D.3.11.10	Medicinal product containing genetically modified organisms	No
D.3.11.11	Herbal medicinal product	No
D.3.11.12	Homeopathic medicinal product	No
D.3.11.13	Another type of medicinal product	No
D.IMP: 3
D.1.2 and D.1.3	IMP Role	Comparator
D.2	Status of the IMP to be used in the clinical trial
D.2.1	IMP to be used in the trial has a marketing authorisation	Yes
D.2.1.1.1	Trade name	Pegasys
D.2.1.1.2	Name of the Marketing Authorisation holder	Hoffmann-La Roche Inc.
D.2.1.2	Country which granted the Marketing Authorisation	United States
D.2.5	The IMP has been designated in this indication as an orphan drug in the Community	No
D.2.5.1	Orphan drug designation number
D.3 Description of the IMP
D.3.4	Pharmaceutical form	Solution for injection
D.3.4.1	Specific paediatric formulation	No
D.3.7	Routes of administration for this IMP	Subcutaneous use
D.3.8 to D.3.10 IMP Identification Details (Active Substances)
D.3.8	INN - Proposed INN	PEGINTERFERON ALFA-2A
D.3.9.1	CAS number	198153-51-4
D.3.9.2	Current sponsor code	NA
D.3.9.3	Other descriptive name	NA
D.3.9.4	EV Substance Code	SUB16452MIG
D.3.10	Strength
D.3.10.1	Concentration unit	µg/ml microgram(s)/millilitre
D.3.10.2	Concentration type	equal
D.3.10.3	Concentration number	360
D.3.11 The IMP contains an:
D.3.11.1	Active substance of chemical origin	No
D.3.11.2	Active substance of biological/ biotechnological origin (other than Advanced Therapy IMP (ATIMP)	Yes
	The IMP is a:
D.3.11.3	Advanced Therapy IMP (ATIMP)	No
D.3.11.3.1	Somatic cell therapy medicinal product	No
D.3.11.3.2	Gene therapy medical product	No
D.3.11.3.3	Tissue Engineered Product	No
D.3.11.3.4	Combination ATIMP (i.e. one involving a medical device)	No
D.3.11.3.5	Committee on Advanced therapies (CAT) has issued a classification for this product	No
D.3.11.4	Combination product that includes a device, but does not involve an Advanced Therapy	No
D.3.11.5	Radiopharmaceutical medicinal product	No
D.3.11.6	Immunological medicinal product (such as vaccine, allergen, immune serum)	No
D.3.11.7	Plasma derived medicinal product	No
D.3.11.8	Extractive medicinal product	No
D.3.11.9	Recombinant medicinal product	No
D.3.11.10	Medicinal product containing genetically modified organisms	No
D.3.11.11	Herbal medicinal product	No
D.3.11.12	Homeopathic medicinal product	No
D.3.11.13	Another type of medicinal product	No

D.8 Information on Placebo

E. General Information on the Trial

E.1 Medical condition or disease under investigation

E.1.1

Medical condition(s) being investigated

Chronic Genotype 2 or 3 HCV infection.

Infezione cronica da HCV genotipo 2 o 3.

E.1.1.1

Medical condition in easily understood language

Hepatitis C Virus Infection.

Infezione da virus dell'epatite C.

E.1.1.2

Therapeutic area

Diseases [C] - Virus Diseases [C02]

MedDRA Classification

E.1.2 Medical condition or disease under investigation

E.1.2	Version	14.1
E.1.2	Level	LLT
E.1.2	Classification code	10047457
E.1.2	Term	Viral hepatitis C
E.1.2	System Organ Class	10021881 - Infections and infestations

E.1.3

Condition being studied is a rare disease

E.2 Objective of the trial

E.2.1

Main objective of the trial

To determine the efficacy of PSI-7977 in combination with RBV administered for 12 weeks compared with PEG/RBV administered for 24 weeks in treatment-naïve patients with HCV genotype 2 or 3 as assessed by the rate of SVR12 (HCV RNA <LOQ 12 weeks after cessation of therapy).

Determinare l’efficacia di PSI-7977 in associazione con RBV somministrato per 12 settimane in confronto a PEG/RBV somministrato per 24 settimane a pazienti naïve al trattamento, con infezione da HCV di genotipo 2 o 3 come risulta dalla valutazione del tasso di RVS12 (HCV RNA <LOQ 12 settimane dopo la cessazione della terapia).

E.2.2

Secondary objectives of the trial

•To assess the safety and tolerability of PSI-7977/RBV administered for 12 weeks as measured by the frequency of deaths, serious adverse events (SAEs), discontinuations due to AEs, and Grade 3 or 4 laboratory abnormalities •To determine the SVR at Week 24 (SVR24) following completion of treatment for each investigational arm (HCV RNA <LOQ 24 weeks after cessation of therapy) •To evaluate the change in circulating HCV RNA in patients over 12 or 24 weeks of dosing •To determine the proportion of patients with HCV RNA below the lower limit of quantitation (LOQ) and lower limit of detection (LOD) at various time points thoughout the study •To determine the proportion of patients whose ALT normalizes during therapy •To describe rates of virologic failure •To characterize HCV drug resistance substitutions at baseline, during, and after therapy with PSI-7977.

•Valutare la sicurezza e tollerabilità di PSI-7977/RBV somministrato per 12 settimane sulla base della frequenza dei decessi, degli eventi avversi seri (SAE - Serious Adverse Events), dell’abbandono dovuto ad eventi avversi e dei risultati anomali di laboratorio di grado 3 o 4 •Determinare la RVS alla Settimana 24 (RVS24) dopo la fine del trattamento di ciascun braccio sperimentale (HCV RNA <LOQ 24 settimane dopo la cessazione della terapia) •Valutare la variazione nella quantità di HCV RNA in circolo nei pazienti nell’arco di 12 o 24 settimane di somministrazione •Determinare la proporzione di pazienti affetti da infezione da HCV RNA al di sotto del limite inferiore di quantificazione (LOQ - limit of quantitation) e del limite inferiore di rilevabilità (LOD - limit of detection) in diversi momenti nel corso dello studio. (Si veda la sinossi del protocollo in italiano).

E.2.3

Trial contains a sub-study

E.3

Principal inclusion criteria

1) Males or females at least 18 years old, or the legal age of consent, whichever is older, at Screening. Subjects or their heterosexual partner(s) must either be of non-childbearing potential or they must use effective contraception from 2 weeks before the initiation of therapy until 6 months (or the duration recommended locally for ribavirin if longer) after the last dose of study medication. 2) Chronic Genotype 2 or 3 HCV-infection documented by at least one measurement of serum HCV RNA ≥ 10,000 IU/mL 3) Patients with Childs A cirrhosis may be included (up to 20% of patients randomized) 4) Subjects must be naïve to all HCV antiviral treatment(s), including but not limited to immunomodulatory and nucleoside/tide treatments for chronic HCV infection. 5) A body mass index (BMI) of ≥18kg/m2 6) Otherwise suitable for participation as determined by the medical history, physical examination, ECG, and clinical laboratory measurements performed at Screening 7) Able to effectively communicate with the Investigator and other center personnel. Willing to give written informed consent and comply with the study restrictions and requirements.

1) maschi o femmine di almeno 18 anni di età, al momento dello screening. I soggetti oi loro partner eterosessuali (s) non devono essere in grado di concepire o devono utilizzare un contraccettivo efficace da 2 settimane prima dell'inizio della terapia fino a 6 mesi (o durata raccomandata a livello locale per la ribavirina, se più lunga) dopo l'ultima dose dei farmaci in studio. 2)infezione documentata cronica da HCV genotipo 2 o 3 da almeno una misurazione di HCV RNA nel siero ≥ 10.000 UI/mL 3) I pazienti con cirrosi A Childs possono essere inclusi (fino al 20% dei pazienti randomizzati) 4) I soggetti devono essere naive a tutti i trattamenti antivirali per HCV inclusi ma non solo i trattamenti immunomodulatori e nucleoside/tide per infezione cronica da HCV. 5) Un indice di massa corporea (BMI) ≥ 18kg/m2 6) In caso contrario, adatto per la partecipazione come stabilito dalla anamnesi, esame fisico, ECG, e misurazioni cliniche di laboratorio effettuate al momento dello screening 7) In grado di comunicare efficacemente con lo sperimentatore e l'altro personale del centro. Disposto a dare il consenso informato scritto e rispettare le restrizioni e i requisiti dello studio.

E.4

Principal exclusion criteria

1) Positive test at Screening for HBsAg, anti-HBc IgM Ab, or anti-HIV Ab. 2) History of any other clinically significant chronic liver disease. 3) A history of consistent with decompensated liver disease including ascites, variceal hemorrhage, hepatic encephalopathy, hepatorenal syndrome and hepatopulmonary syndrome, among others. 4) History or current evidence of psychiatric illness, immunologic disorder, hemoglobinopathy, pulmonary or cardiac disease, seizure disorder or anticonvulsant use, poorly controlled diabetes, cancer, or a history of malignancy that in the opinion of the investigator makes the patient unsuitable for the study. Chronic medical conditions, especially if treated with medications (such as hypertension), must be stable at the time of screening. No new therapies should be started prior to the study that may confound the assessment of study drug safety. 5) Clinical signs and symptoms of acute pancreatitis with elevated lipase.

1) Test positivo allo screening per l'HBsAg, Ab anti-HBc IgM, o anti-HIV Ab. 2) Storia o evidenza di altra malattia cronica del fegato clinicamente significativa. 3)Storia di malattia epatica scompensata tra cui ascite, emorragia da varici esofagee, encefalopatia epatica, sindrome epato-renale e la sindrome epatopolmonare, tra le altre. 4) Storia o attuale malattia psichiatrica, disturbi immunologici, emoglobinopatie, malattie polmonari o cardiache, disturbi convulsivi o uso di anticonvulsivante, diabete scarsamente controllato, cancro o una storia di tumore maligno che, a giudizio dello sperimentatore rende il paziente inadatto al studio. Condizione medica cronica, specialmente se trattate con farmaci (come ipertensione), deve essere stabile al momento dello screening. Non devono essere iniziate nuove terapie prima dello studio che possono confondere la valutazione della sicurezza del farmaco in studio. 5)segni clinici e sintomi di pancreatite acuta con lipasi elevata.

E.5 End points

E.5.1

Primary end point(s)

Serum HCV RNA, viral resistance testing.

RNA di HCV nel siero, test di resistenza virale.

E.5.1.1

Timepoint(s) of evaluation of this end point

The primary study hypothesis is that PSI-7977/RBV administered for 12 weeks will be superior to PEG/RBV administered for 24 weeks. The primary efficacy endpoint is sustained viral response 12 weeks post last dose of any treatment (HCV RNA <LOQ 12 weeks after cessation of therapy) in the ITT population. The primary analyses will include the assessments non-inferiority (with a non-inferiority margin of 15%) and the superiority PSI-7977/RBV (Arm A) to the control (Arm B). A closed testing procedure will be performed for the primary analyses

L'ipotesi principale dello studio è che PSI-7977/RBV somministrato per 12 settimane sarà superiore al PEG/RBV somministrati per 24 settimane. L'endpoint primario di efficacia è la risposta virale sostenuta alle 12 settimane dopo l'ultima dose di qualsiasi trattamento (HCV RNA <LOQ 12 settimane dopo l'interruzione della terapia) nella popolazione ITT. Le analisi primarie comprendono le valutazioni di non-inferiorità (con un margine di non inferiorità del 15%) e la superiorità di PSI-7977/RBV (braccio A) rispetto al controllo (braccio B). Una procedura di test chiuso sarà effettuata per le analisi primarie.

E.5.2

Secondary end point(s)

1) Safety: Adverse events (AE), safety labs, electrocardiograms (ECGs) and vital signs. 2) Pharmacokinetic parameters: Population pharmacokinetic parameters for PSI-6206.

1) Sicurezza: Eventi Avversi(EA), dati di sicurezza di laboratorio, elettrocardiogrammi (ECGs) e segni vitali. 2) Parametri farmacocinetici: parametri della popolazione farmacocinetica per PSI-6206.

E.5.2.1

Timepoint(s) of evaluation of this end point

Safety endpoints will be analyzed as the number and percent of subjects with events or abnormalities for categorical values or descriptive statistics.

Gli endpoint di sicurezza saranno analizzati come il numero e la percentuale di soggetti con eventi o anomalie per i valori categorici o statistiche descrittive.

E.6 and E.7 Scope of the trial

E.6

Scope of the trial

E.6.1

Diagnosis

E.6.2

Prophylaxis

E.6.3

Therapy

E.6.4

Safety

Yes

E.6.5

Efficacy

Yes

E.6.6

Pharmacokinetic

Yes

E.6.7

Pharmacodynamic

Yes

E.6.8

Bioequivalence

E.6.9

Dose response

E.6.10

Pharmacogenetic

E.6.11

Pharmacogenomic

E.6.12

Pharmacoeconomic

E.6.13

Others

Yes

E.6.13.1

Other scope of the trial description

tolerability

tollerabilità

E.7

Trial type and phase

E.7.1

Human pharmacology (Phase I)

E.7.1.1

First administration to humans

E.7.1.2

Bioequivalence study

E.7.1.3

Other

E.7.1.3.1

Other trial type description

E.7.2

Therapeutic exploratory (Phase II)

E.7.3

Therapeutic confirmatory (Phase III)

Yes

E.7.4

Therapeutic use (Phase IV)

E.8 Design of the trial

E.8.1

Controlled

Yes

E.8.1.1

Randomised

Yes

E.8.1.2

Open

Yes

E.8.1.3

Single blind

E.8.1.4

Double blind

E.8.1.5

Parallel group

Yes

E.8.1.6

Cross over

E.8.1.7

Other

E.8.2

Comparator of controlled trial

E.8.2.1

Other medicinal product(s)

Yes

E.8.2.2

Placebo

E.8.2.3

Other

E.8.2.4

Number of treatment arms in the trial

E.8.3

The trial involves single site in the Member State concerned

E.8.4

The trial involves multiple sites in the Member State concerned

Yes

E.8.4.1

Number of sites anticipated in Member State concerned

E.8.5

The trial involves multiple Member States

Yes

E.8.5.1

Number of sites anticipated in the EEA

E.8.6 Trial involving sites outside the EEA

E.8.6.1

Trial being conducted both within and outside the EEA

Yes

E.8.6.2

Trial being conducted completely outside of the EEA

E.8.6.3

If E.8.6.1 or E.8.6.2 are Yes, specify the regions in which trial sites are planned

Australia

Canada

Korea, Republic of

New Zealand

Puerto Rico

United States

E.8.7

Trial has a data monitoring committee

Yes

E.8.8

Definition of the end of the trial and justification where it is not the last visit of the last subject undergoing the trial

LVLS

E.8.9 Initial estimate of the duration of the trial

E.8.9.1

In the Member State concerned years

E.8.9.1

In the Member State concerned months

E.8.9.1

In the Member State concerned days

E.8.9.2

In all countries concerned by the trial years

E.8.9.2

In all countries concerned by the trial months

E.8.9.2

In all countries concerned by the trial days

F. Population of Trial Subjects

F.1 Age Range

F.1.1

Trial has subjects under 18

F.1.1

Number of subjects for this age range:

F.1.1.1

In Utero

F.1.1.2

Preterm newborn infants (up to gestational age < 37 weeks)

F.1.1.3

Newborns (0-27 days)

F.1.1.4

Infants and toddlers (28 days-23 months)

F.1.1.5

Children (2-11years)

F.1.1.6

Adolescents (12-17 years)

F.1.2

Adults (18-64 years)

Yes

F.1.2.1

Number of subjects for this age range:

450

F.1.3

Elderly (>=65 years)

Yes

F.1.3.1

Number of subjects for this age range:

F.2 Gender

F.2.1

Female

Yes

F.2.2

Male

Yes

F.3 Group of trial subjects

F.3.1

Healthy volunteers

F.3.2

Patients

Yes

F.3.3

Specific vulnerable populations

Yes

F.3.3.1

Women of childbearing potential not using contraception

F.3.3.2

Women of child-bearing potential using contraception

Yes

F.3.3.3

Pregnant women

F.3.3.4

Nursing women

F.3.3.5

Emergency situation

F.3.3.6

Subjects incapable of giving consent personally

F.3.3.7

Others

F.4 Planned number of subjects to be included

F.4.1

In the member state

F.4.2

For a multinational trial

F.4.2.1

In the EEA

145

F.4.2.2

In the whole clinical trial

500

F.5

Plans for treatment or care after the subject has ended the participation in the trial (if it is different from the expected normal treatment of that condition)

Standard care.

Terapia standard.

G. Investigator Networks to be involved in the Trial

N. Review by the Competent Authority or Ethics Committee in the country concerned

Competent Authority Decision

Authorised

Date of Competent Authority Decision

2012-03-15

Ethics Committee Opinion of the trial application

Favourable

Ethics Committee Opinion: Reason(s) for unfavourable opinion

Date of Ethics Committee Opinion

2012-02-23

P. End of Trial
P.	End of Trial Status	Completed

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IMP with orphan designation in the indication
Orphan Designation Number:
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