Status:
COMPLETED
Safety and Efficacy of SCH 503034 in Previously Untreated Subjects With Chronic Hepatitis C Infected With Genotype 1 (Study P03523)
Lead Sponsor:
Merck Sharp & Dohme LLC
Conditions:
Chronic Hepatitis C
Eligibility:
All Genders
18-60 years
Phase:
PHASE2
Brief Summary
This was an open-label, randomized safety and efficacy trial in adult, treatment-naïve Chronic Hepatitis C (CHC) participants with genotype 1 infection. The study conducted in 2 parts, compared standa...
Detailed Description
The study was conducted in 2 parts. Part 1 of the study had 5 arms using weight based ribavirin 800-1400 mg/day and compared: * PegIntron and ribavirin for 48 weeks (Arm 1 - Control) * PegIntron, ri...
Eligibility Criteria
Inclusion
- Age between 18 and 60 years;
- Body weight between 45 and 125 kg;
- Documented chronic hepatitis C genotype 1;
- Liver biopsy with histology consistent with chronic hepatitis and no other etiology for chronic liver disease within of 5 years of Day 1;
- Participant and participant's partner(s) must each agree to use acceptable methods of contraception 2 weeks prior to Day 1 and at least 6 months after the last dose of study medication;
- Written informed consent.
Exclusion
- Include, but are not limited to, the following:
- Prior treatment for hepatitis C;
- Co-infection with HIV or hepatitis B virus (HBsAg positive);
- Evidence of decompensated liver disease;
- Diabetic and hypertensive participants with clinically significant ocular exam findings;
- Pre-existing psychiatric condition, including but not limited to:
- Current moderate or severe depression;
- History of depression associated with any of the following:
- Hospitalization for depression;
- Electroconvulsive therapy for depression;
- Depression that resulted in a prolonged absence from work and/or significant disruption of daily functions;
- Suicidal or homicidal ideation and/or attempt;
- History of severe psychiatric disorders (including but not limited to schizophrenia, psychosis, bipolar disorder, post-traumatic stress disorder or mania);
- Past history or current use of lithium;
- Past history or current use of antipsychotic drugs for listed conditions.
- Substance abuse within protocol specified timeframes;
- Pre-existing medical conditions that could interfere with the participant's participation in and completion of the study, including but not limited to chronic pulmonary disease, cardiac dysfunction or immunologically-mediated disease;
- Active or suspected malignancy or history of malignancy within the past 5 years;
- Participants who are pregnant or nursing; participants who intend to become pregnant during the study period. Male participants with partners who are, or intend to become, pregnant during the study period.
- Treatment with any investigational drug or participation in any clinical trial 30 days within Screening;
- Hemoglobin \<12 g/dL for females and \<13 g/dL for males;
- Neutrophils \<1500 mm\^3; Blacks: \<1200/mm\^3;
- Platelets \<100,000/mm\^3;
- Other clinically significant laboratory test abnormalities.
Key Trial Info
Start Date :
January 1 2007
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
November 1 2008
Estimated Enrollment :
765 Patients enrolled
Trial Details
Trial ID
NCT00423670
Start Date
January 1 2007
End Date
November 1 2008
Last Update
April 5 2017
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