Peg-Intron/Ribavirin in G 1 HCV for Non-Extended Versus 24 Week Extended Treatment After 24 Weeks (Study P04144)
Information source: Schering-Plough
Information obtained from ClinicalTrials.gov on June 20, 2008
Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Hepatitis C, Chronic
Intervention: Combination of pegylated interferon alfa-2b and ribavirin (Drug)
Phase: Phase 4
Status: Active, not recruiting
Sponsored by: Schering-Plough
Official(s) and/or principal investigator(s):
Ding-Shinn Chen, MD, Study Chair, Affiliation: Investigational Site
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 subjects with a diagnosis of compensated chronic hepatitis C (hepatitis C
virus (HCV)-ribonucleic acid (RNA) positive) (Genotype 1). All subjects will complete 24
weeks of treatment, termed the Pilot Treatment Program, after which all eligible subjects
will be randomly assigned to one of two study groups. One group will be followed for an
additional 48 weeks without study medication, while the other will be continuously treated
for an additional 24 weeks and then followed for another 24 weeks without study medication.
Sustained virologic response, defined as undetectable HCV-RNA in serum at the end of the
follow-up period, will be measured along with other outcomes.
Official title: Comparison of the Sustained Response of Peg-Intron/Ribavirin Combination Therapy in Genotype 1-Infected Hepatitis C Patients for Non-Extended Versus 24-Week Extended Treatment After 24 Weeks Pilot Treatment in Taiwan
Study design: Treatment, Randomized, Open Label, Dose Comparison, Parallel Assignment, Safety/Efficacy Study
Primary outcome: The proportion of individuals who are able to achieve a sustained virologic response (SVR), defined as HCV-RNA levels below assay detection 24 weeks after termination of anti-HCV therapy
Secondary outcome: The proportion of individuals who are able to achieve a virologic response 48 weeks after randomization.
This is an open-label, randomized, comparative, multicenter study for evaluation of
Peg-Intron/Ribavirin therapy in the efficacy and safety in adult subjects with a diagnosis of
compensated chronic hepatitis C (HCV-RNA+) (Genotype 1). This is a 48-week study, for which
all subjects should participate in the Pilot Treatment Program and complete 24 weeks
treatment. To avoid a treatment gap, subjects who will be screened and eligible subjects
will sign informed consent prior to the end of the Pilot Treatment Program. After completion
of the Pilot Treatment Program, all eligible subjects will be randomly assigned to either
study group. Subjects of Group 1 will be followed-up without study medication for 48 weeks;
Group 2 will be continuously treated for another 24 weeks and all subjects of Group 2 will be
followed for another 24 weeks after completion of the treatment period. Subjects of both
groups will be evaluated at screening, randomization, 4, 8, 12, 16, 20, 24, 28, 36 and 48
weeks after randomization.
Minimum age: 18 Years.
Maximum age: 65 Years.
- 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 X109/L
- Platelets count >= 100 x 109/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 109/L
- Platelets count >= 50 x 109/L
- PT prolong <= 3 sec, 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-HIV negative.
- 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 +
- 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.
- 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
- 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.
Locations and Contacts
Investigational Site 1, Taipei 100, Taiwan
Investigational Site 3, Taipei 112, Taiwan
Investigational Site 4, Taipei 112, Taiwan
Investigational Site 6, Tainan 704, Taiwan
Investigational Site 7, Kaoshiung 833, Taiwan
Investigational Site 8, Kaoshiung 807, Taiwan
Investigational Site 9, Kaoshiung 813, Taiwan
Investigational Site 10, Kaoshiung 812, Taiwan
Investigational Site 2, Taoyuan county 333, Taiwan
Investigational Site 5, Taipei 114, Taiwan
Starting date: March 2005
Ending date: July 2008
Last updated: June 16, 2008