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Pegylated Interferon and Ribavirin Therapy in Chronic Hepatitis Genotype 4

NCT00277862 · Status: COMPLETED · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 280

Last updated 2008-02-26

No results posted yet for this study

Summary

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.

Conditions

  • Hepatitis C

Interventions

DRUG

Pegylated IFN- alpha 2b

DRUG

Ribavirin

Sponsors & Collaborators

  • Schering-Plough

    collaborator INDUSTRY

  • Fulbright

    collaborator OTHER

  • Tempus AI

    collaborator INDUSTRY

  • International Society for Infectious Diseases

    collaborator OTHER

  • Ain Shams University

    lead OTHER

Principal Investigators

  • Sanaa M Kamal, M.D.; Ph.D · AUS Specialized Hospital, Cairo, Cairo, 11351, Egypt;

  • Amany Sayed Ahmad, M.D. · DIAGSERA

  • Samer El Kamary · UMB

  • Amal Abdel Baky, M.D. · DIGSERA

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
55 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2002-04-30
Primary Completion
2007-03-31
Completion
2007-04-30

Countries

  • Egypt

Study Locations

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Entities

Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00277862 on ClinicalTrials.gov