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    Summary
    EudraCT Number:2008-004761-26
    Sponsor's Protocol Code Number:2008-004761-26
    National Competent Authority:Italy - Italian Medicines Agency
    Clinical Trial Type:EEA CTA
    Trial Status:Prematurely Ended
    Date on which this record was first entered in the EudraCT database:2008-12-23
    Trial 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
    Expand All   Collapse All
    A. Protocol Information
    A.1Member State ConcernedItaly - Italian Medicines Agency
    A.2EudraCT number2008-004761-26
    A.3Full title of the trial
    PILOT MULTICENTER OPEN STUDY TO EVALUATE EFFICACY AND TOLERABILITY OF PEG-INTERFERON ALFA-2A IN PATIENTS WITH ANTI-HBE POSITIVE CHRONIC HEPATITIS B WHO PRESENT RESIDUAL VIREMIA OR VIROLOGICAL REBOUND DURING NUCLEOS(T)IDE ANALOGUE TREATMENT
    A.3.2Name or abbreviated title of the trial where available
    SPEACH-B
    A.4.1Sponsor's protocol code number2008-004761-26
    A.5.1ISRCTN (International Standard Randomised Controlled Trial) Number2008-004761-26
    A.7Trial is part of a Paediatric Investigation Plan Information not present in EudraCT
    A.8EMA Decision number of Paediatric Investigation Plan
    B. Sponsor Information
    B.Sponsor: 1
    B.1.1Name of SponsorAZIENDA OSPEDALIERA UNIVERSITARIA DELLA SECONDA UNIVERSITA` DEGLI STUDI DI NAPOLI
    B.1.3.4CountryItaly
    B.3.1 and B.3.2Status of the sponsorNon-Commercial
    B.4 Source(s) of Monetary or Material Support for the clinical trial:
    B.4.1Name of organisation providing support
    B.4.2Country
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisation
    B.5.2Functional name of contact point
    D. IMP Identification
    D.IMP: 1
    D.1.2 and D.1.3IMP RoleTest
    D.2 Status of the IMP to be used in the clinical trial
    D.2.1IMP to be used in the trial has a marketing authorisation Yes
    D.2.1.1.1Trade name PEGASYS
    D.2.1.1.2Name of the Marketing Authorisation holderROCHE SpA
    D.2.1.2Country which granted the Marketing AuthorisationItaly
    D.2.5The IMP has been designated in this indication as an orphan drug in the Community No
    D.2.5.1Orphan drug designation number
    D.3 Description of the IMP
    D.3.4Pharmaceutical form Solution for injection
    D.3.4.1Specific paediatric formulation Information not present in EudraCT
    D.3.7Routes of administration for this IMPSubcutaneous use
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNPeginterferon alfa-2a
    D.3.10 Strength
    D.3.10.1Concentration unit µg/ml microgram(s)/millilitre
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number180
    D.3.11 The IMP contains an:
    D.3.11.1Active substance of chemical origin No
    D.3.11.2Active substance of biological/ biotechnological origin (other than Advanced Therapy IMP (ATIMP) Yes
    The IMP is a:
    D.3.11.3Advanced Therapy IMP (ATIMP) Information not present in EudraCT
    D.3.11.3.1Somatic cell therapy medicinal product No
    D.3.11.3.2Gene therapy medical product No
    D.3.11.3.3Tissue Engineered Product Information not present in EudraCT
    D.3.11.3.4Combination ATIMP (i.e. one involving a medical device) Information not present in EudraCT
    D.3.11.3.5Committee on Advanced therapies (CAT) has issued a classification for this product Information not present in EudraCT
    D.3.11.4Combination product that includes a device, but does not involve an Advanced Therapy Information not present in EudraCT
    D.3.11.5Radiopharmaceutical medicinal product No
    D.3.11.6Immunological medicinal product (such as vaccine, allergen, immune serum) No
    D.3.11.7Plasma derived medicinal product No
    D.3.11.8Extractive medicinal product No
    D.3.11.9Recombinant medicinal product Information not present in EudraCT
    D.3.11.10Medicinal product containing genetically modified organisms No
    D.3.11.11Herbal medicinal product No
    D.3.11.12Homeopathic medicinal product No
    D.3.11.13Another type of medicinal product Yes
    D.3.11.13.1Other medicinal product typeANTIVIRALE- IMMUNOSTIMOLANTE
    D.8 Information on Placebo
    E. General Information on the Trial
    E.1 Medical condition or disease under investigation
    E.1.1Medical condition(s) being investigated
    Patients with chronic hepatitis B, HBeAg-negative, on treatment with nucleos(t)ide analogues.
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 9.1
    E.1.2Level HLGT
    E.1.2Classification code 10019654
    E.1.2Term Hepatic and hepatobiliary disorders
    E.1.3Condition being studied is a rare disease No
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    Primary:
    To assess the efficacy of Peginterferon alfa-2a for 48 weeks used in monotherapy after 4 weeks of combination with nucleos(t)ide in patients with chronic hepatitis B, HBeAg-negative who present residual viremia or virological rebound during nucleos(t)ide analogues treatment.
    E.2.2Secondary objectives of the trial
    Secondary:
    To assess the safety of Peginterferon alfa-2a for 48 weeks used in monotherapy after 4 weeks of combination with nucleos(t)ide in patients with chronic hepatitis B, HBeAg-negative who present residual viremia or virological rebound during nucleos(t)ide analogues treatment.
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    Inclusion criteria:
    1. Chronic hepatitis B anti-HBe positive or Cirrhosis Child-Pugh A5 without portal hypertension signs on analogue treatment
    2. Age 18-65 years
    3. HBV DNA > 60 IU/mL to 2,000 IU/mL (HBV DNA > 300 cp/mL to 10,000 cp/mL) at least six months of therapy OR HBV-DNA increase ³ 1log10 but < 20,000 IU/mL versus the previous HBV-DNA assessment performed within 4 weeks before
    4. Able to participate, and willing to give written informed consent and to comply with the study restrictions
    E.4Principal exclusion criteria
    Exclusion criteria:
    1. ALT > 10 ULN
    2. Presence of cirrhosis with a Child-Pugh score > 5, esophageal varices &amp;#8805; F2, history or evidence of ascites or bleeding
    3. A positive result in HBeAg, HCV, anti-HDV or HIV tests
    4. History or evidence of other causes of liver disease associated to HBV (haemochromatosis, alcoholic hepatitis, etc)
    5. Autoimmune diseases;
    6. A neutrophil count <1,500/mm3 or platelets <70,000/mm3
    7. Haemoglobin <11.5 for women and 12.5 g/dL for men
    8. Serum creatinine >1.5 the ULN
    9. Significant renal disease
    10. AFP >100 ng/mL; patients with AFP values >20 but <100 ng/mL can be enrolled if liver US is negative for nodules
    11. Diagnosis of hepatocellular carcinoma
    12. History or evidence of psychiatric disease, particularly of depression
    13. Alcohol consumption >30 g/dL for men or 20 g/dL for women
    14. Drug abuse
    15. History of seizures or use of anti-epileptic drugs
    16. Heart disease (NYHA 3 or 4) or other significant heart abnormality
    17. Organ transplant recipients
    18. Uncontrolled thyroid dysfunction
    19. Retinal diseases
    20. If female of child-bearing potential, a positive urine pregnancy test
    21. Lactating women
    22. Participation in an investigational drug study within three months prior to screening
    23. Concomitant disease or condition that could interfere with, or for which the treatment of might interfere with, the conduct of the study, or that would, in the opinion of the investigator, pose an unacceptable risk to the subject in this study
    24. Any confirmed significant allergic reactions against any drug, or multiple allergies
    E.5 End points
    E.5.1Primary end point(s)
    Primary Endpoint:
    The reduction of HBV-DNA levels to below 2,000 IU/mL (10,000 cp/mL) after 24 weeks of untreated follow-up period.
    E.6 and E.7 Scope of the trial
    E.6Scope of the trial
    E.6.1Diagnosis No
    E.6.2Prophylaxis No
    E.6.3Therapy Yes
    E.6.4Safety Yes
    E.6.5Efficacy Yes
    E.6.6Pharmacokinetic No
    E.6.7Pharmacodynamic No
    E.6.8Bioequivalence No
    E.6.9Dose response No
    E.6.10Pharmacogenetic No
    E.6.11Pharmacogenomic No
    E.6.12Pharmacoeconomic No
    E.6.13Others No
    E.7Trial type and phase
    E.7.1Human pharmacology (Phase I) No
    E.7.1.1First administration to humans No
    E.7.1.2Bioequivalence study No
    E.7.1.3Other No
    E.7.1.3.1Other trial type description
    E.7.2Therapeutic exploratory (Phase II) No
    E.7.3Therapeutic confirmatory (Phase III) Yes
    E.7.4Therapeutic use (Phase IV) No
    E.8 Design of the trial
    E.8.1Controlled No
    E.8.1.1Randomised No
    E.8.1.2Open Yes
    E.8.1.3Single blind No
    E.8.1.4Double blind No
    E.8.1.5Parallel group No
    E.8.1.6Cross over No
    E.8.1.7Other No
    E.8.2 Comparator of controlled trial
    E.8.2.1Other medicinal product(s) Information not present in EudraCT
    E.8.2.2Placebo Information not present in EudraCT
    E.8.2.3Other Information not present in EudraCT
    E.8.3 The trial involves single site in the Member State concerned No
    E.8.4 The trial involves multiple sites in the Member State concerned Yes
    E.8.4.1Number of sites anticipated in Member State concerned15
    E.8.5The trial involves multiple Member States No
    E.8.6 Trial involving sites outside the EEA
    E.8.6.1Trial being conducted both within and outside the EEA No
    E.8.6.2Trial being conducted completely outside of the EEA Information not present in EudraCT
    E.8.7Trial has a data monitoring committee No
    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
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years2
    E.8.9.1In the Member State concerned months0
    E.8.9.1In the Member State concerned days
    E.8.9.2In all countries concerned by the trial years2
    E.8.9.2In all countries concerned by the trial months0
    F. Population of Trial Subjects
    F.1 Age Range
    F.1.1Trial has subjects under 18 No
    F.1.1.1In Utero No
    F.1.1.2Preterm newborn infants (up to gestational age < 37 weeks) No
    F.1.1.3Newborns (0-27 days) No
    F.1.1.4Infants and toddlers (28 days-23 months) No
    F.1.1.5Children (2-11years) No
    F.1.1.6Adolescents (12-17 years) No
    F.1.2Adults (18-64 years) Yes
    F.1.3Elderly (>=65 years) No
    F.2 Gender
    F.2.1Female Yes
    F.2.2Male Yes
    F.3 Group of trial subjects
    F.3.1Healthy volunteers No
    F.3.2Patients Yes
    F.3.3Specific vulnerable populations No
    F.3.3.1Women of childbearing potential not using contraception No
    F.3.3.2Women of child-bearing potential using contraception No
    F.3.3.3Pregnant women No
    F.3.3.4Nursing women No
    F.3.3.5Emergency situation No
    F.3.3.6Subjects incapable of giving consent personally No
    F.3.3.7Others No
    F.4 Planned number of subjects to be included
    F.4.1In the member state60
    G. Investigator Networks to be involved in the Trial
    N. Review by the Competent Authority or Ethics Committee in the country concerned
    N.Competent Authority Decision Authorised
    N.Date of Competent Authority Decision2009-03-26
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2008-12-16
    P. End of Trial
    P.End of Trial StatusPrematurely Ended
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