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    The EU Clinical Trials Register currently displays   35443   clinical trials with a EudraCT protocol, of which   5820   are clinical trials conducted with subjects less than 18 years old.
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    Summary
    EudraCT Number:2005-003876-39
    Sponsor's Protocol Code Number:P04371
    National Competent Authority:Belgium - FPS Health-DGM
    Clinical Trial Type:EEA CTA
    Trial Status:Prematurely Ended
    Date on which this record was first entered in the EudraCT database:2006-08-30
    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
    Expand All   Collapse All
    A. Protocol Information
    A.1Member State ConcernedBelgium - FPS Health-DGM
    A.2EudraCT number2005-003876-39
    A.3Full title of the trial
    A Randomized, Open-label, Multi-center, Phase 3, 2-arm Study Evaluating the Efficacy and Safety of Peg interferon Alfa-2b Low-dose Maintenance Monotherapy Versus Standard Supportive Care in Patients With Cirrhotic Hepatitis C Co-infected With Human Immunodeficiency Virus – The ENDURE Study.
    A.3.2Name or abbreviated title of the trial where available
    ENDURE
    A.4.1Sponsor's protocol code numberP04371
    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 SponsorIntegrated Therapeutics Group, Incorporated-a subsidiary of Schering Plough
    B.1.3.4CountryUnited States
    B.3.1 and B.3.2Status of the sponsorCommercial
    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 PegIntron
    D.2.1.1.2Name of the Marketing Authorisation holderSP Europe
    D.2.1.2Country which granted the Marketing AuthorisationEuropean Union
    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.3.1Product namePEGIntron
    D.3.2Product code SCH 54031
    D.3.4Pharmaceutical form 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 alpha-2b/ standard supportive care
    D.3.9.1CAS number 215647-85-1
    D.3.9.2Current sponsor codeSCH 54031
    D.3.9.3Other descriptive namePEGIntron
    D.3.10 Strength
    D.3.10.1Concentration unit µg/ml microgram(s)/millilitre
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number50 / 50 to 150 vials / 100 p
    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 No
    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
    Cirrhotic Hepatitis C Co-infected With Human Immunodeficiency Virus
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 9.0
    E.1.2Level LLT
    E.1.2Classification code 10019641
    E.1.3Condition being studied is a rare disease No
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    To compare throughout the study the efficacy of PEG-Intron® monotherapy versus standard supportive care, using the time to the first occurrence of any one of the following clinical events (death, liver decompensation, liver transplant, hepatocellular carcinoma), in the two treatment groups .
    E.2.2Secondary objectives of the trial
    To compare the two treatment groups at the EOS:
    a) & b) The times and incidence to each of the following EOS: Overall mortality, Liver-related mortality, Liver decompensation, Liver transplants, Hepatocellular carcinoma (HCC)
    1. To investigate the safety profile of PEG-Intron in comparison with standard supportive care.
    2. To assess the effect of PEG-Intron low dose maintenance treatment on HIV infection progression as determined by: a. changes in CD4 cell count levels, b. changes in HIV RNA titers, c. HIV related infections, d. ART regimen changes.
    3. Changes in serum ALT and HCV RNA.
    4. Changes in Fibro Scan and APRI during the study period.
    5. Changes in hepatic venous pressure gradient (HVPG) levels in a subgroup of subjects from the two treatment groups with available data.
    6. Changes in proliferative histological indices and fibrotic scores in a subgroup of paired liver biopsies at the beginning and EOS. Liver biopsies will be obtained from the two treatment groups.
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    To be eligible for enrollment, subjects must meet the following inclusion criteria:
    1) Display the willingness and ability to participate in the study by demonstrating full comprehension of and agreement to comply with all study procedures by signing the written informed consent.
    2) ≥18 years but < 70 years, of either sex or any race.
    3) Detectable plasma HCV RNA with all genotypes of HCV permitted. Historical PCR and genotype are acceptable for study entry and will be confirmed at screening through the central lab.
    4) Previous non-responders or intolerant to any pegylated alpha interferon plus ribavirin (cannot be on therapy for 2 weeks prior to randomization) or subjects unwilling to complete a full course of any combination treatment (pegylated alpha interferon plus ribavirin) are eligible for this study.
    5) Cirrhosis of the liver, confirmed by histopathologic findings.
    6) Compensated liver disease measured by the Child-Pugh clinical classification with the hepatic encephalopathy measure equal to one and the total score less than or equal to 8.
    7) No evidence of HCC on abdominal ultrasound, CT scan, or MRI scan, and a serum AFP <100 ng/mL within 90 days of randomization/study .
    8) Endoscopy to determine if evidence of bleeding (prior or present) due to esophageal varices, gastric varices, or portal gastropathy within six months of randomization/study enrollment. (If evidence of prior variceal bleeding, the patient is not eligible for the study).
    9) Serologic evidence of HIV infection by HIV antibody or detection of HIV RNA. (Historical HIV RNA is acceptable for study entry and will be confirmed at screening through a central lab).
    10) CD4 cell count ≥100 /µL, regardless of HIV RNA load.
    11) Platelet number of at least 50000 mm3.
    12) Neutrophil count of at least 750 mm3.
    13) Hemoglobin of >9.0 g/dL.
    14) Any serum ALT/AST liver enzyme level.
    15) Serum thyroid stimulating hormone levels within normal limits, regardless of treatment with L thyroxin.
    16) HbA1c<8.5%, to demonstrate controlled diabetes, if applicable.
    17) Written clearance from an ophthalmologist must be presented for subjects with a history of hypertension or diabetes prior to treatment start.
    18) Creatinine clearance >50 mL/min, as assessed by the indirect calculation method (Appendix 5).
    19) Demonstrate stable status of HIV infection, in the opinion of the principal investigator, (e.g., subjects who are expected to progress in the first 3 months of the study would not be appropriate for enrollment).
    20) On stable antiretroviral therapy (HAART) for at least 8 weeks prior to baseline.
    OR
    21) Willing to delay initiation of HAART therapy for at least 6 weeks (for subjects who have not been on HAART for at least 8 weeks prior to randomization).
    22) Counseled in the appropriate use of birth control while in this study, as confirmed by the principal investigator or a sub-investigator.
    23) While abstinence from sexual activity is the only certain method to prevent pregnancy, female subjects of childbearing potential (includes women who are less than two years post-menopausal and women who may become sexually active during the study) must agree to use a medically acceptable barrier method of contraception (or be surgically sterilized prior to screening) while receiving protocol-specified medication and for one month after stopping the medication.
    (a) Acceptable methods of contraception include condoms (male and female) with a spermicidal agent, diaphragm or cervical cap with spermicide, medically prescribed IUD, oral or injectable hormonal contraceptive, and surgical sterilization (e.g., hysterectomy or tubal ligation)
    (b) Male subjects who are sexually active must be using an acceptable method of contraception (vasectomy, condoms with spermicide). Contraception must be used during the treatment period and for one month after the completion of therapy, including condom use by male subjects with pregnant partners.
    24) Confirmation by the principal investigator or a sub-investigator that sexually active male/female subjects are practicing a method of contraception considered acceptable Contraception must be used during the treatment period and for 1 month after the completion of therapy, including condom use by male subjects with pregnant partners. For subjects who take possible teratogenic HAART regimen (e.g., efavirenz) additional counseling should be given in regard to contraception.
    25) Free of any clinically significant disease (other than HCV and HIV) that would interfere with study evaluations.
    E.4Principal exclusion criteria
    Any subject will be excluded from entry into the study if they have ANY of the following criteria:
    1) Female who is pregnant, intends to become pregnant during the study or within two months after study completion, or is nursing. Male subjects whose partner wants to become pregnant.
    2) Using silymarin.
    3) Positive test at screening for anti-HAV IgM Ab, HBsAg, anti-HBc IgM Ab, or HBeAg.
    4) Any cause of liver disease other than chronic hepatitis C, including—but not limited to:
    a) Hemochromatosis
    b) Alpha-1 antitrypsin deficiency
    c) Wilson's disease
    d) Autoimmune hepatitis
    e) Alcoholic liver disease
    f) Non-alcoholic steatohepatitis (NASH)
    g) Drug-related liver disease
    5) Suspected or having hypersensitivity to interferon.
    6) History of liver decompensation status or other evidence of bleeding from esophageal varices, signs of current bleeding, significant ascites, hepatic encephalopathy, jaundice or other conditions consistent with decompensated liver disease.
    7) Present with a lesion suspicious for hepatic malignancy (HCC or metastasis/metastases) on the screening imaging.
    8) Any active malignant disease, suspicion, or history of malignant disease within 5 years prior to study enrollment (except for adequately treated basal cell carcinoma).
    9) Known coagulation (e.g., hemophilia) or hemoglobin (e.g., thalassemia) diseases that in the opinion of the investigator presents a risk to the patient to participate in the study
    10) Organ transplant, except corneal or hair transplant.
    11) Any known preexisting medical condition that, in the investigator’s opinion, could interfere with the subject's participation in and completion of the study, such as:
    a) Preexisting psychiatric condition, especially moderate to severe depression, or a history of severe psychiatric disorder, such as psychosis, suicidal ideation, or suicide attempts. Severe depression includes the following:
    i) Hospitalization for depression
    ii) Electroconvulsive therapy for depression, or
    iii) Depression causing a prolonged absence from work or significantly altering daily functions.
    Subjects with mild depression may be considered for entry into the study provided that a pre-treatment assessment demonstrates that the subject’s emotional status is clinically stable (either on or off drugs), in which case a management plan must be formulated for the subject; this management plan will become a part of the subject 's medical record.
    b) Craniocerebral trauma which is not a concussion, or active seizure disorders requiring medication
    c) Clinically significant ECG abnormalities and/or cardiovascular dysfunction within six previous months (e.g., angina, congestive heart failure, recent myocardial infarction, or significant arrhythmia)
    d) Chronic lung disease (e.g., chronic obstructive lung disease)
    e) Poorly controlled diabetes mellitus
    f) Immune-mediated disease (e.g., inflammatory bowel disease [Crohn's disease, ulcerative colitis], idiopathic thrombocytopenic purpura, systemic lupus erythematosus, autoimmune hemolytic anemia, scleroderma, severe psoriasis)
    g) Clinical gout
    12) Active HIV-related opportunistic infection and/or malignancy requiring systemic therapy.
    13) Evidence of known severe retinopathy (e.g., CMV retinitis, macular degeneration).
    14) Subjects that in the investigator's opinion are non-reliable for the study conduct or therapy drug administration. These subjects may be – but not limited to – illicit drug/alcohol users whether on substitution therapy or not.
    15) Subject has not observed the designated washout periods for any of the prohibited medications outlined in Section 6.2.
    16) Participating in any other Hepatitis C clinical study. Subjects who chose to participate in other HIV investigational drugs study may do this if the other protocol allows.
    17) Subject is part of the staff or a family member of the staff personnel directly involved with this study.
    18) Any other condition that in the opinion of the investigator will make the subject unsuitable for enrollment or will interfere with the subject participating in or completing the study.
    E.5 End points
    E.5.1Primary end point(s)
    The primary endpoint is to measure the time to the first occurrence of any one of the clinical end points (death, liver decompensation, liver transplant and HCC) in the two treatment groups.

    Secondary endpoints include:
    1. To measure time to death and incidence of deaths in the two treatment groups.
    2. To measure time to liver related deaths and liver related deaths incidence at the end of the study in the two treatment groups.
    3. To measure time to liver decompensation and liver decompensation incidence in the two treatment groups.
    4. To measure time to liver transplant and transplant incidence in the two treatment groups.
    5. To measure time to HCC and HCC incidences in the two treatment groups.
    6. To measure incidence of combined clinical events in the two treatment groups.
    7. To measure and compare the incidence of the treatment dose discontinuation rate, study discontinuation rate, and total SAE's in subjects in the two treatment groups. Thus, to determine whether PEG-Intron has any in vivo interaction with HAART.
    8. To measure the effect of PEG-Intron on low dose maintenance treatment on HIV disease progression:
    a. Incidence of subjects with an increase in HIV RNA >0.5 log while on stable HAART therapy.
    b. Incidence of subjects with a > 50 CD4 cells/cc drop, or >50% whichever is bigger.
    c. Incidence of subjects and time to progression to AIDS defining events- defined in Appendix 7.
    d. Incidence of subjects’ HAART regimen modification and/or discontinuation.
    9. To measure changes in biochemical markers (serum ALT and APRI) and HCV RNA during the study period.
    10. To measure changes in Fibro Scan during the study period.
    11. To measure the changes in hepatic venous pressure gradient (HVPG) levels in a subgroup of subjects from the two treatment groups with the available data.
    12. To score, in paired liver biopsies, the Metavir and Ishak - fibrosis score and histological index at the end of the study in the 2 treatment groups.
    E.6 and E.7 Scope of the trial
    E.6Scope of the trial
    E.6.1Diagnosis No
    E.6.2Prophylaxis Yes
    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 Yes
    E.8.1.1Randomised Yes
    E.8.1.2Open Yes
    E.8.1.3Single blind No
    E.8.1.4Double blind No
    E.8.1.5Parallel group Yes
    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 Yes
    E.8.2.3.1Comparator description
    Standard Supportive Care - defined by local country guidelines
    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 concerned2
    E.8.5The trial involves multiple Member States Yes
    E.8.5.1Number of sites anticipated in the EEA90
    E.8.6 Trial involving sites outside the EEA
    E.8.6.1Trial being conducted both within and outside the EEA Yes
    E.8.6.2Trial being conducted completely outside of the EEA Information not present in EudraCT
    E.8.6.3If E.8.6.1 or E.8.6.2 are Yes, specify the regions in which trial sites are planned
    E.8.7Trial 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
    End of trial: when the last subject has completed the last visit (36 months) or when 80 subjects experienced at least 1 endpoint related clinical event, which ever is sooner.
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years3
    E.8.9.1In the Member State concerned months
    E.8.9.1In the Member State concerned days
    E.8.9.2In all countries concerned by the trial years3
    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) Yes
    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 Yes
    F.3.3.1Women of childbearing potential not using contraception For clinical trials recorded in the database before the 10th March 2011 this question read: "Women of childbearing potential" and did not include the words "not using contraception". An answer of yes could have included women of child bearing potential whether or not they would be using contraception. The answer should therefore be understood in that context. This trial was recorded in the database on 2006-08-30. Yes
    F.3.3.2Women of child-bearing potential using contraception Yes
    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 state20
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 224
    F.4.2.2In the whole clinical trial 448
    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 Decision2006-09-19
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2006-09-08
    P. End of Trial
    P.End of Trial StatusPrematurely Ended
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