Pegylated Interferon and Ribavirin Therapy in Chronic Hepatitis Genotype 4

February 25, 2008 updated by: Ain Shams University

Role of Rapid Virologic Response in Determining Treatment Duration of Peginterferon Alfa-2b/Ribavirin in Chronic Hepatitis C Genotype 4

Genotype 4 is the least-studied hepatitis C virus genotype and was considered a difficult to treat genotype due to the disappointing response of chronic hepatitis C genotype 4 to conventional interferon monotherapy. Recent reports showed that pegylated interferon and ribavirin combination therapy markedly increased the SVR rate to 55-70%. The duration of treatment has not been accurately defined. The main objective of this is to assess the duration of pegylated interferon ribavirin therapy in chronic hepatitis genotype 4 and assess the clinical utility of rapid and early virologic response in determining the optimal duration of peg interferon ribavirin therapy in chronic hepatitis C.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

Hepatitis C virus (HCV) genotype 4 is the most frequent cause of chronic hepatitis C in Middle East, North Africa and sub-Saharan Africa. In countries like Egypt, 73 to 90% of cases of chronic hepatitis C are caused by genotype 4. Recently, epidemiological reports showed spread of HCV-4 infection in Western countries such as France, Italy, Greece, Spain and the United States particularly among intravenous drug users.

Genotype 4 is the least-studied hepatitis C virus genotype and was considered a difficult to treat genotype due to the disappointing response of chronic hepatitis C genotype 4 to conventional interferon monotherapy. Recent reports showed that pegylated interferon and ribavirin combination therapy markedly increased the SVR rate to 55-70%. We have previously shown that, treatment patients with chronic HVCG4with PEG-IFN α-2b plus ribavirin for 36 or 48 weeks was more effective (SVR 66% and 69%, respectively) than for 24 weeks.

It has been shown in previous studies on chronic hepatitis C genotype 1 that individuals who achieve an early virologic have a higher chance to achieve a sustained virologic response. Peg interferon and ribavirin therapy is associated with adverse events and is expensive; therefore, careful determination of the optimal treatment duration is crucial as it spares the patient unnecessary or prolonged therapy and enhances the cost-effectiveness of therapy.

Therefore the main objective of this randomized, multicenter trial is to assess the clinical utility of rapid and early virologic response in determining the optimal duration of peg interferon ribavirin therapy in chronic hepatitis C.

Study Type

Interventional

Enrollment (Actual)

280

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Egypt
      • Cairo, Egypt
        • DIACSERA
      • Cairo, Egypt
        • MISR Welding
      • Mynia and Cairo, Egypt
        • ELectricity Auth
    • Cairo,
      • Cairo;, Cairo,, Egypt, 11351,
        • AUS Specialized Hospital,

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 55 years (Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:Adult males and females, 18 to 50 years of age; with documented chronic hepatitis C according to the following criteria: elevated serum alanine aminotransferase (ALT) above the upper limit of normal (40 U/l) on two occasions during the preceding six months; anti-HCV positive anti-body status assessed by second generation enzyme linked immunosorbent assay (Roche Diagnostics, Branchburg, New Jersey, USA); positive polymerase chain reaction for HCV RNA (Cobas Amplicor HCV Monitor v2.0; lower limit of quantitation 50 IU/mL); genotype 4; and criteria for chronic hepatitis C in liver biopsy performed within the preceding year with no signs of cirrhosis or bridging fibrosis on pretreatment liver biopsy.

-

Exclusion Criteria:

  • Previous IFN-alpha therapy; other liver diseases such as hepatitis A, hepatitis B, schistosomiasis, autoimmune hepatitis, alcoholic liver disease, drug induced hepatitis, or decompensated liver disease; coinfection with schistosomiasis or human immunodeficiency virus; neutro¬penia (,1 500/mm3); thrombocytopenia (,90 000/mm3); creatinine concentration .1.5 times the upper limit of normal; serum a fetoprotein concentration .25 ng/ml; organ transplant; neoplastic disease; severe cardiac or pulmonary disease; unstable thyroid dysfunction; psychiatric disorder; current pregnancy or breast feeding; or therapy with immunomodulatory agents within the last six months.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: 1
  1. Pegylated IFN- alpha 2b
  2. Ribavirin for 24 weeks (patients with RVR)
Drug: Ribavirin
Other Names:
  • Rebetol
  • Virin
  • Ribavrin
Drug: Pegylated IFN- alpha 2b
Other Names:
  • PEG-IFN alpha-2b
  • PEG-Intron™
Active Comparator: 2
  1. Pegylated IFN- alpha 2b
  2. Ribavirin for 36 weeks (patients with complete EVR)
Drug: Ribavirin
Other Names:
  • Rebetol
  • Virin
  • Ribavrin
Drug: Pegylated IFN- alpha 2b
Other Names:
  • PEG-IFN alpha-2b
  • PEG-Intron™
Active Comparator: 3
  1. Pegylated IFN- alpha 2b
  2. Ribavirin for 48 weeks (patients with partial EVR)
Drug: Ribavirin
Other Names:
  • Rebetol
  • Virin
  • Ribavrin
Drug: Pegylated IFN- alpha 2b
Other Names:
  • PEG-IFN alpha-2b
  • PEG-Intron™
Active Comparator: 4
  1. Pegylated IFN- alpha 2b
  2. Ribavirin for 48 weeks (control)
Drug: Ribavirin
Other Names:
  • Rebetol
  • Virin
  • Ribavrin
Drug: Pegylated IFN- alpha 2b
Other Names:
  • PEG-IFN alpha-2b
  • PEG-Intron™

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
sustained virologic response defined as undetectable serum HCV RNA levels (Amplicor HCV, Roche Molecular Systems; lower limit of detection (LLD) of 50 IU/mL)
Time Frame: 18 months
18 months

Secondary Outcome Measures

Outcome Measure
Time Frame
Virologic response at the end of treatment (EOT) defined as undetectable HCV RNA serum levels (50 IU/ml) at the end of the scheduled treatment period
Time Frame: 6-12 months and 6 months follow-up
6-12 months and 6 months follow-up
sustained virologic response (primary) histological response (secondary) biochemical response (secondary)
Time Frame: 6-12 months treatment), 6 months follow-up
6-12 months treatment), 6 months follow-up

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Ain Shams University

Collaborators

Schering-Plough
Tempus Labs
Fulbright
International Society for Infectious Diseases

Investigators

  • Principal Investigator: Sanaa M Kamal, M.D.; Ph.D, AUS Specialized Hospital, Cairo, Cairo, 11351, Egypt;
  • Principal Investigator: Amany Sayed Ahmad, M.D., DIAGSERA
  • Principal Investigator: Samer El Kamary, UMB
  • Principal Investigator: Amal Abdel Baky, M.D., DIGSERA

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

April 1, 2002

Primary Completion (Actual)

March 1, 2007

Study Completion (Actual)

April 1, 2007

Study Registration Dates

First Submitted

January 15, 2006

First Submitted That Met QC Criteria

January 15, 2006

First Posted (Estimate)

January 18, 2006

Study Record Updates

Last Update Posted (Estimate)

February 26, 2008

Last Update Submitted That Met QC Criteria

February 25, 2008

Last Verified

February 1, 2008

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • G43230832638

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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