Infliximab Treatment Along With Pegylated Interferon and Ribavirin in the Treatment of Hepatitis C

NCT00512278 | Completed Phase 2 Results DMC

• 1 other identifier: PARTNER
• Study Type: interventional
• Target: 146
• Locations: 1 country
• Sites: 7

Brief Summary

The aim of the study is to investigate in subjects receiving their first course of peg-interferon α-2b plus ribavirin therapy for chronic HCV infection

Conditions

Hepatitis C

Keywords

Hepatitis; HCV; Hepatitis C

Outcome Measures

Primary Outcomes (2)

• A Comparison of the Percentage of Chronic Hepatitis C Subjects (Treatment Naive,Genotype 1) Who Achieve SVR at Week 72, After 48 Weeks of Treatment.

  A comparison of the Proportion of Chronic Hepatitis C Subjects (Treatment Naive,Genotype 1) Who Achieve SVR at Week 72, After 48 Weeks of TreatmentSVR in both study arms

  72 Weeks from initiation of treatment

• Number of Participants Achieving Sustained Virological Response (SVR)

  HCV RNA negativity at 24 weeks after completion of all study medications

  24 weeks after completion of all study medications

Secondary Outcomes (3)

• A Comparison of the Percentage of Participants With Non-detectable HCV-RNA After 24 Weeks of Therapy.

  24 weeks

• Percentage of Participants Experiencing Serious Adverse Events

  72 Weeks from initiation of treatment

• Percentage of Participants Experiencing Medically Significant Infections

  72 weeks from initiation of treatment

Study Arms (2)

Infliximab

EXPERIMENTAL

Infliximab: 48 weeks of therapy with the combination of PEG INF-2b/RBV plus adjuvant infliximab

Drug: Infliximab

Placebo

PLACEBO COMPARATOR

Placebo: 48 weeks of therapy with Placebo and PEG INF-2b/RBV

Drug: Placebo

Interventions

Infliximab DRUG

Infliximab weight based injection at baseline, weeks 2,6,14,22,30,38,46

Also known as: Remicade

Infliximab

Placebo DRUG

Placebo

Placebo

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Male or female subjects, \>18 years of age with proven chronic (greater than 6 months) hepatitis C infection (genotype 1) who have never been treated with pegylated interferon α-2b and /or ribavirin.
• Male or female, 18 years of age or older
• Positive HCV RNA, Genotype 1, treatment naïve (never received pegylated interferon and / or ribavirin)
• Evidence of chronic HCV infection for at least six months prior to screening
• Findings on liver biopsy within the past 36 months that are consistent with the presence of chronic hepatitis C infection.
• Negative hepatitis B surface antigen
• No evidence of hemochromatosis
• Hemoglobin ≥12 g/dL for females and ≥13 g/dL for males
• WBC ≥3.0 x 109/L and neutrophils ≥1.5 x 109/L
• Platelets ≥80 x109/L
• Direct Bilirubin WNL +/- 50% of central laboratory normal range. Total bilirubin ≤1.6.
• Albumin within normal limits
• Serum creatinine within normal limits.
• Serum thyroid stimulating hormone (TSH) levels within normal limits
• Men and women of childbearing potential must use two forms of adequate birth control measures for the duration of the study and should continue such precautions for 6 months after receiving the last infusion.

You may not qualify if:

• Women who are pregnant, nursing, or planning pregnancy within 6 months after the last infusion and men with partners who are pregnant at baseline or intend to become pregnant within 6 months after the last infusion.
• Known allergy against infliximab, ribavirin, or pegylated interferon
• Decompensated liver disease characterized as decreased hepatic synthetic functioning with abnormal albumin and bilirubin levels, prolonged prothrombin time or complications including ascites or recent variceal bleeding
• have a history of latent or active granulomatous infection, including TB, histoplasmosis, or coccidiomycosis (Valley Fever)
• History of autoimmune hepatitis or a history of poorly controlled autoimmune disease
• Use of other systemic anti-inflammatory medication except NSAIDs and low dose systemic steroids
• Previous treatment with monoclonal antibodies or antibody fragments
• History of receiving human/murine recombinant products or a known allergy to murine products
• Documentation of seropositive for human immunodeficiency virus (HIV)
• History of alcohol or substance abuse within the preceding 6 months that, in the opinion of the investigator, may increase the risks associated with study participation or study agent administration, or may interfere with interpretation of results
• History of serious infections (e.g., hepatitis, pneumonia or pyelonephritis) in the previous 3 months
• Opportunistic infection within 6 months prior to screening
• History of lymphoproliferative disease
• Currently have any known malignancy or have a history of malignancy within the previous 5 years, with the exception of basal cell or squamous cell carcinoma of the skin that has been fully excised with no evidence of recurrence
• Current signs or symptoms of severe, progressive or uncontrolled renal, hepatic, hematologic, gastrointestinal, endocrine, pulmonary, cardiac, neurologic, or cerebral disease

Sponsors & Collaborators

• Nizar Zein: lead
• Centocor, Inc.: collaborator

Study Sites (7)

Cedars-Sinai Medical Center, Center for Liver Disease and Transplantation

Los Angeles, California, 90048, United States

Location

Advanced Medical Research Center

Port Orange, Florida, 32127, United States

Location

University of Louisville

Louisville, Kentucky, 440292, United States

Location

Case Medical Center

Cleveland, Ohio, 44106, United States

Location

Cleveland Clinic

Cleveland, Ohio, 44195, United States

Location

The Liver Institute at Methodist Dallas

Dallas, Texas, 75203, United States

Location

Brooke Army Medical Center

San Antonio, Texas, 78234, United States

Location

MeSH Terms

Conditions

Hepatitis C; Hepatitis

Interventions

Infliximab

Condition Hierarchy (Ancestors)

Blood-Borne Infections; Communicable Diseases; Infections; Hepatitis, Viral, Human; Virus Diseases; Flaviviridae Infections; RNA Virus Infections; Liver Diseases; Digestive System Diseases

Intervention Hierarchy (Ancestors)

Antibodies, Monoclonal; Antibodies; Immunoglobulins; Immunoproteins; Blood Proteins; Proteins; Amino Acids, Peptides, and Proteins; Serum Globulins; Globulins

Results Point of Contact

• Title: Nizar Zein
• Organization: Cleveland Clinic

zeinn@ccf.org

216-444-6126

Study Officials

• Nizar N Zein, MD

  The Cleveland Clinic

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Associate Professor of Medicine; Chief, Section of Hepatobiliary Diseases; Medical Director of Liver Transplantation

Study Record Dates

• First Submitted: August 3, 2007
• First Posted: August 7, 2007
• Study Start: July 1, 2007
• Primary Completion: May 1, 2012
• Study Completion: May 1, 2012
• Last Updated: September 13, 2017
• Results First Posted: September 13, 2017

Record last verified: 2017-08

Data Sharing

• IPD Sharing: Will not share

Locations

US (7)