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Effect of Infliximab on the Efficacy of Peg-Intron/Ribavirin in Patients With Hepatitis C (Study P04257AM4)(COMPLETED) | Clinical Trials | Clareo Health

COMPLETEDPHASE3

Effect of Infliximab on the Efficacy of Peg-Intron/Ribavirin in Patients With Hepatitis C (Study P04257AM4)(COMPLETED)

Effect of Infliximab in Hepatitis-C Genotype 1 Naïve Patients With High TNF-alpha on the Efficacy of Pegylated Interferon Alfa-2b/Ribavirin Therapy

NCT00237484•Merck Sharp & Dohme LLC

View on ClinicalTrials.gov

Summary

This is a Phase IIIB, randomized, prospective, multicenter, single-country, open-label, controlled pilot trial designed to evaluate the effect of infliximab induction therapy on sustained virologic response (SVR) to treatment with pegylated interferon alfa-2b plus ribavirin in a group of 96 therapy-naïve subjects with genotype 1 hepatitis C virus (HCV) infection and high serum tumor necrosis factor (TNF)-alpha values.

Eligibility

Age

18 - 65 years

Sex

ALL

Healthy Volunteers

Inclusion Criteria

•Subjects must demonstrate their willingness to participate in the study and comply with its procedures by signing a written informed consent.
•Subjects must be 18 to 65 years of age.
•HCV genotype 1 (including mixtures of subtypes of genotype 1).
•Naïve to interferon (any formulation) and ribavirin.
•Serum TNF-alpha \>300 pg/mL(single measure at Pre-Screen Visit).
•HCV ribonucleic acid (RNA) positive.
•Any alanine aminotransferase (ALT) level.
•Fasting glucose should be 3.8-6.2 mmol/L. Results between 6.3-7.8 mmol/L require a HbA1c \<=8.5%. All diabetic subjects must have an HbA1c \<=8.5%, whether on medication or diet controlled.
•Liver biopsy within 24 months of enrolment demonstrating Stage 0-3 fibrosis (Metavir System).
•Compensated liver disease with the following minimum hematological, biochemical, and serological criteria at the screen visit (WNL = within normal limits):
+10 more criteria

Exclusion Criteria

•Women who are pregnant or nursing.
•Subjects who have not observed the designated washout periods for any of the prohibited medications.
•Subjects who have used any investigational product within 30 days prior to enrollment.
•Acute HCV infection defined as infection for \<6 months.
•Male partners to/or Heterosexually active women of childbearing potential not practicing a highly effective form of contraception.
•Positive screening for tuberculosis (TB) or Tuberculin Skin Test \> 5mm.
•History or presence of cirrhosis (Stage 4 on Metavir System) and/or complication such as ascites, bleeding varices or hepatic encephalopathy
•Active hepatitis B virus (HBV) infection (hepatitis B surface antigen \[HBsAg\] positive).
•Any known pre-existing psychiatric condition that could interfere with the subject's participation in and completion of the study such as:
•* Pre-existing psychiatric condition, including but not limited to moderate to severe depression, or a history of severe psychiatric disorders, such as psychosis, suicidal ideation and/or suicidal attempt
+31 more criteria

Key Dates

Start Date

July 18, 2005

Primary Completion Date

June 30, 2011

Completion Date

June 30, 2011

Last Updated

August 26, 2020

Enrollment

ACTUAL participants

Conditions

Hepatitis C, Chronic

Interventions

Induction dose of (a) infliximab followed by combination of (b) pegylated interferon alfa-2b and (c) ribavirin

DRUG

Combination of (a) pegylated interferon alfa-2b and (b) ribavirin

DRUG

Digitalized Surveillance Management for Liver Cancer Risk Population in Improving Eearly Diagnosis Efficancy in Chinese Population (dSEARCH)

NCT05870969

Carcinoma, HepatocellularHepatitis C, Chronic+3 more

View study

COMPLETEDPHASE4

The No One Waits Study: Acceptability and Feasibility of Community-based Point-of-diagnosis HCV Treatment Study

NCT03987503

Hepatitis C, Chronic

View study

Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: August 26, 2020Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

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Effect of Infliximab on the Efficacy of Peg-Intron/Ribavirin in Patients With Hepatitis C (Study P04257AM4)(COMPLETED)

Inclusion Criteria

Exclusion Criteria

Digitalized Surveillance Management for Liver Cancer Risk Population in Improving Eearly Diagnosis Efficancy in Chinese Population (dSEARCH)

The No One Waits Study: Acceptability and Feasibility of Community-based Point-of-diagnosis HCV Treatment Study

Treatment of Chronic Hepatitis C During Pregnancy With Sofosbuvir/Velpatasvir

Safety And Efficacy Of Oral PF-4136309 In Patients With Chronic Hepatitis C Infection And Abnormal Liver Enzymes

Addition of ISIS 14803 to Therapy With Peginterferon and Ribavirin for Chronic Hepatitis C (HCV) Patients Not Responding Adequately to the Two Drugs

The Pharmacokinetics of P1101 + Ribavirin in Interferon Treatment-Naïve Subjects With Chronic Hepatitis C Virus (HCV) Genotype 2 Infection