Status:
COMPLETED
Peg-Intron/Ribavirin in G 1 HCV for Non-Extended Versus 24 Week Extended Treatment After 24 Weeks (Study P04144)(COMPLETED)
Lead Sponsor:
Merck Sharp & Dohme LLC
Conditions:
Hepatitis C, Chronic
Eligibility:
All Genders
18-65 years
Phase:
PHASE4
Brief Summary
This is an open-label, randomized, comparative, multicenter, 48-week study designed to evaluate the efficacy and safety of combination treatment with pegylated interferon and ribavirin in adult subjec...
Detailed Description
This is an open-label, randomized, comparative, multicenter study for evaluation of PegIntron/Ribavirin therapy in the efficacy and safety in adult subjects with a diagnosis of compensated chronic hep...
Eligibility Criteria
Inclusion
- Subject must be willing to give written informed consent and be able to adhere to dose and visit schedules.
- Males and non-pregnant females and aged \>= 18 years, subjects who are over 65 years of age must be in generally good health and must be discussed with and approved by the principal investigator prior to entry.
- The laboratory evaluation within 6 months prior to entering the Pilot Treatment Program must meet the following criteria:
- Hemoglobin values of \>= 12 g/dL for females and \>= 13 g/dL for males
- Neutrophil count \>= 1.5 X10\^9/L
- Platelets count \>= 100 x 10\^9/L
- Total bilirubin \< 1.5 mg/dL
- Serum creatinine within normal limits
- Positive serum HCV-RNA (\>= 50 IU (100 copy numbers)/mL)
- Anti-HCV positive
- Available HCV genotype 1
- Liver biopsy performed within 12 months prior to entry to this protocol with a pathology report confirming that the histological diagnosis is consistent with chronic hepatitis (METAVIR system \>=F1).
- Compensated liver disease with the following hematological, biochemical, and serologic criteria at the screening visit:
- Hemoglobin values of \>= 9 g/dL
- Neutrophil count \>= 0.75 x 10\^9/L
- Platelets count \>= 50 x 10\^9/L
- Prothrombin time (PT) prolong \<= 3 sec, International Normalized Ratio (INR) \<= 1.2
- Total bilirubin \<= 3 mg/dL
- Within normal limits (subjects requiring medication to maintain TSH levels in the normal range are eligible if all other inclusion/exclusion criteria are met).
- Anti-Human Immunodeficiency Virus (HIV) negative.
- Alpha-fetoprotein (AFP) value within normal limits obtained within 12 months prior to entry. Results above the upper limit of normal but \<= 50 ng/mL require both of the following:
- AFP value \<= 50 ng/mL obtained within 9 months prior to entry in the study or during the Screening period, and Ultrasound obtained within 9 months prior to entry or in the screening period in the study for evidence of not having hepatocellular carcinoma.
- A urine pregnancy test obtained prior to the initiation of pilot treatment must be negative. Female subjects must not be breast feeding.
- Reconfirmation that sexually-active subjects are practicing acceptable methods of contraception during screening period.
- Complete 24 weeks treatment of the Pilot Treatment Program with Peg-Intron + Ribavirin.
- Must be never treated with interferon for HCV infected hepatitis (treatment naïve) before the Pilot Treatment Program.
- The total amount of Peg-Intron and Ribavirin received during the pilot treatment program must achieve more than 80% of the recommended dosage.
Exclusion
- Women who are pregnant or nursing.
- Have decompensated cirrhosis.
- History of severe psychiatric disease, especially depression.
- Concurrent malignancies (including hepatocellular carcinoma).
- Unstable or significant cardiovascular diseases. Subjects with (ECG) showing clinically significant abnormalities.
- Prolonged exposure to known hepatotoxins such as alcohol or drugs.
- History of thyroid disease poorly controlled on prescribed medication.
- Poorly controlled diabetes mellitus.
- Has suspected or confirmed significant hepatic disease from an etiology other than HCV.
- Patients co-infected with hepatitis B and /or human immunodeficiency virus (HIV).
- Severe renal disease or myeloid dysfunction.
- History of organ transplantation other than cornea and hair transplant.
- Any medical condition requiring, or likely to require during the course of the study, chronic systemic administration of steroids.
- Any other condition which in the opinion of the investigator would make the subject unsuitable for enrollment, or could interfere with the subject participating in and completing the protocol.
- Allergy to interferon.
Key Trial Info
Start Date :
March 1 2005
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
July 1 2008
Estimated Enrollment :
160 Patients enrolled
Trial Details
Trial ID
NCT00202839
Start Date
March 1 2005
End Date
July 1 2008
Last Update
April 6 2017
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