Back to resultsEfficacy and Safety of 24 vs 48 Weeks of Pegetron® (Peginterferon Alfa-2b + Ribavirin) in Naïve Genotype 1 Hepatitis C (Study P05016)(TERMINATED)
Primary Purpose
Hepatitis C, Chronic
Status
Terminated
Phase
Phase 3
Locations
Study Type
Interventional
Intervention
Combination of pegylated interferon alfa-2b (PEG) and ribavirin (RBV)
Sponsored by
About this trial
This is an interventional treatment trial for Hepatitis C, Chronic
Eligibility Criteria
Inclusion Criteria:
- Must demonstrate willingness to participate in the study.
- Diagnosed with chronic HCV.
- Between 18 and 65 years of age of either gender and of any race.
- a. HCV positive, >600,000 IU/mL at baseline AND b. Genotype 1.
- Suitable for treatment with Pegetron® per the Canadian product monograph.
- Investigator has already decided to treat with PEGETRON REDIPEN®
1.5mcg/kg/week of peginterferon alpha-2b plus 800-1200 mg /day of ribavirin.
- HCV-RNA negative at treatment week 4.
- Meet certain minimum laboratory values at the week 4 screening visit.
- Women of childbearing potential and male partners must agree to use a medically accepted method of contraception prior to screening, while receiving protocol-specified medication, and for 6 months after stopping the medication. Acceptable methods of contraception include condoms (male or female) with or without 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).
Exclusion Criteria:
- Had previous interferon-based therapy for Chronic Hepatitis C.
- Active Hepatitis B virus (HBV) infection.
- Human Immunodeficiency Virus (HIV) antibody positive.
- Cirrhotic (Stage 4 on Metavir system).
- Uncontrolled history or current severe depression or psychoses.
- Uncontrolled epilepsy.
- Use of illicit drugs.
- History of non-compliance to medical regimens.
- Liver disease other than from chronic hepatitis C.
- Participating in any other clinical study.
- Used any investigational drugs within 30 days of screening.
- Participants weighing < 40 kg or > 125 kg.
- Pregnant women or women who plan to become pregnant or sexual partners of women who want to become pregnant.
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
Pegetron® - 24 Weeks
Pegetron®- 48 Weeks
Arm Description
Participants are treated with Pegetron® (pegylated interferon alfa-2b and ribavirin) for 8 weeks and then randomized to an additional 16 weeks of treatment
Participants are treated with Pegetron® (pegylated interferon alfa-2b and ribavirin) for 8 weeks and then randomized to an additional 40 weeks of treatment.
Outcomes
Primary Outcome Measures
Number of Participants With a Sustained Virologic Response
Participants were tested for the presence of Hepatitis C Virus-Ribonucleic Acid (HCV-RNA) in blood by Qualitative Polymerase Chain Reaction (qPCR). If the HCV-RNA is not detectable, the participant is negative for HCV-RNA.
Sustained virologic responders were participants negative for HCV-RNA at 24 weeks following the completion of therapy. A Participant that withdrew prior to 24 weeks following the completion of therapy was considered a non-responder.
Secondary Outcome Measures
Number of Participants With a Virological Relapse
Participants were tested for the presence of Hepatitis C Virus-Ribonucleic Acid (HCV-RNA) in blood by Qualitative Polymerase Chain Reaction (qPCR).
Virological relapse in participants was defined as having negative virology (HCV-RNA) at end of treatment, but positive virology (HCV-RNA) again at 24 weeks of follow up post treatment.
Full Information
NCT ID
NCT00423800
First Posted
January 17, 2007
Last Updated
March 9, 2017
Sponsor
Merck Sharp & Dohme LLC
1. Study Identification
Unique Protocol Identification Number
NCT00423800
Brief Title
Efficacy and Safety of 24 vs 48 Weeks of Pegetron® (Peginterferon Alfa-2b + Ribavirin) in Naïve Genotype 1 Hepatitis C (Study P05016)(TERMINATED)
Official Title
Efficacy and Safety of 24 vs 48 Weeks of Pegetron® (Peginterferon Alfa-2b + Ribavirin) Therapy (1.5 mcg/kg/Week + 800-1200 mg/Day) in Naïve Genotype 1 Hepatitis C Patients With High Baseline Viral Load Who Are HCV-RNA Negative at Week 4 and Week 12
Study Type
Interventional
2. Study Status
Record Verification Date
March 2017
Overall Recruitment Status
Terminated
Why Stopped
The study was terminated due to difficulty in recruiting participants.
Study Start Date
December 2006 (undefined)
Primary Completion Date
October 2009 (Actual)
Study Completion Date
October 2009 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Merck Sharp & Dohme LLC
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief Summary
This is a Phase IIIB randomized, controlled, multi-centre, open-label study of 24 versus 48 weeks therapy with Pegetron® (peginterferon alfa-2b + ribavirin) at standard doses in naïve Hepatitis C Virus (HCV) genotype 1 high viral load (HVL) participants who are Hepatitis C Virus-Ribonucleic Acid (HCV-RNA) negative at Week 4. HVL will be defined as HCV-RNA of >600,000 IU/mL prior to the initiation of therapy. Participants with genotype 1 baseline HVL prescribed Pegetron® (peginterferon and ribavirin) in the usual manner in accordance with the marketing authorization and who are viral negative at Week 4 will be randomized at Week 8 to receive a total of 24 or 48 weeks of therapy. Participants will be required to have their baseline and Week-12 viral load analyzed by the same local laboratory using the standard of care test used by the site. Qualitative testing at Week 4, 8, 16-20, 24, and 48 may be conducted either by local laboratory or a central laboratory identified by the sponsor using an assay specified by the sponsor. No additional interventions outside of the clinic's standard of care and the conditions of the Canadian product monograph for Pegetron® will be applied to participants.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Hepatitis C, Chronic
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
56 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Pegetron® - 24 Weeks
Arm Type
Experimental
Arm Description
Participants are treated with Pegetron® (pegylated interferon alfa-2b and ribavirin) for 8 weeks and then randomized to an additional 16 weeks of treatment
Arm Title
Pegetron®- 48 Weeks
Arm Type
Active Comparator
Arm Description
Participants are treated with Pegetron® (pegylated interferon alfa-2b and ribavirin) for 8 weeks and then randomized to an additional 40 weeks of treatment.
Intervention Type
Drug
Intervention Name(s)
Combination of pegylated interferon alfa-2b (PEG) and ribavirin (RBV)
Other Intervention Name(s)
PEGETRON® combination therapy, (a) SCH 54031, PEGETRON® (peginterferon alfa-2b) Powder for Solution, (b) SCH 18908, PEGETRON® (ribavirin) Capsules
Intervention Description
Powder for Solution in Redipen® (pegylated interferon alfa-2b) (80, 100, 120, and 150 microgram strengths), subcutaneous, dose of 1.5 micrograms/kg, weekly for up to 24 or 48 weeks
200 mg ribavirin capsules, oral, weight-based dose of 800, 1000, or 1200 mg, daily for up to 24 or 48 weeks
Primary Outcome Measure Information:
Title
Number of Participants With a Sustained Virologic Response
Description
Participants were tested for the presence of Hepatitis C Virus-Ribonucleic Acid (HCV-RNA) in blood by Qualitative Polymerase Chain Reaction (qPCR). If the HCV-RNA is not detectable, the participant is negative for HCV-RNA.
Sustained virologic responders were participants negative for HCV-RNA at 24 weeks following the completion of therapy. A Participant that withdrew prior to 24 weeks following the completion of therapy was considered a non-responder.
Time Frame
24 weeks following completion of 24 or 48 weeks of therapy
Secondary Outcome Measure Information:
Title
Number of Participants With a Virological Relapse
Description
Participants were tested for the presence of Hepatitis C Virus-Ribonucleic Acid (HCV-RNA) in blood by Qualitative Polymerase Chain Reaction (qPCR).
Virological relapse in participants was defined as having negative virology (HCV-RNA) at end of treatment, but positive virology (HCV-RNA) again at 24 weeks of follow up post treatment.
Time Frame
24 weeks following completion of 24 or 48 weeks of therapy
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Must demonstrate willingness to participate in the study.
Diagnosed with chronic HCV.
Between 18 and 65 years of age of either gender and of any race.
a. HCV positive, >600,000 IU/mL at baseline AND b. Genotype 1.
Suitable for treatment with Pegetron® per the Canadian product monograph.
Investigator has already decided to treat with PEGETRON REDIPEN®
1.5mcg/kg/week of peginterferon alpha-2b plus 800-1200 mg /day of ribavirin.
HCV-RNA negative at treatment week 4.
Meet certain minimum laboratory values at the week 4 screening visit.
Women of childbearing potential and male partners must agree to use a medically accepted method of contraception prior to screening, while receiving protocol-specified medication, and for 6 months after stopping the medication. Acceptable methods of contraception include condoms (male or female) with or without 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).
Exclusion Criteria:
Had previous interferon-based therapy for Chronic Hepatitis C.
Active Hepatitis B virus (HBV) infection.
Human Immunodeficiency Virus (HIV) antibody positive.
Cirrhotic (Stage 4 on Metavir system).
Uncontrolled history or current severe depression or psychoses.
Uncontrolled epilepsy.
Use of illicit drugs.
History of non-compliance to medical regimens.
Liver disease other than from chronic hepatitis C.
Participating in any other clinical study.
Used any investigational drugs within 30 days of screening.
Participants weighing < 40 kg or > 125 kg.
Pregnant women or women who plan to become pregnant or sexual partners of women who want to become pregnant.
12. IPD Sharing Statement
Plan to Share IPD
Yes
IPD Sharing Plan Description
http://www.merck.com/clinical-trials/pdf/Merck%20Procedure%20on%20Clinical%20Trial%20Data%20Access%20Final_Updated%20July_9_2014.pdf
http://engagezone.msd.com/ds_documentation.php
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Efficacy and Safety of 24 vs 48 Weeks of Pegetron® (Peginterferon Alfa-2b + Ribavirin) in Naïve Genotype 1 Hepatitis C (Study P05016)(TERMINATED)
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