Pegylated Interferon and Ribavirin Therapy in Chronic Hepatitis Genotype 4

This study has been completed.
Sponsor:
Collaborators:
Schering-Plough
Fulbright
TEMPUS
International Society for Infectious Diseases
Information provided by:
Ain Shams University
ClinicalTrials.gov Identifier:
NCT00277862
First received: January 15, 2006
Last updated: February 25, 2008
Last verified: February 2008
  Purpose

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.


Condition Intervention Phase
Hepatitis C
Drug: Pegylated IFN- alpha 2b
Drug: Ribavirin
Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Treatment
Official Title: Role of Rapid Virologic Response in Determining Treatment Duration of Peginterferon Alfa-2b/Ribavirin in Chronic Hepatitis C Genotype 4

Resource links provided by NLM:


Further study details as provided by Ain Shams University:

Primary Outcome Measures:
  • 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 ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • 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 ] [ Designated as safety issue: Yes ]
  • sustained virologic response (primary) histological response (secondary) biochemical response (secondary) [ Time Frame: 6-12 months treatment), 6 months follow-up ] [ Designated as safety issue: Yes ]

Enrollment: 280
Study Start Date: April 2002
Study Completion Date: April 2007
Primary Completion Date: March 2007 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: 1
  1. Pegylated IFN- alpha 2b
  2. Ribavirin for 24 weeks (patients with RVR)
Drug: Pegylated IFN- alpha 2b
Other Names:
  • PEG-IFN alpha-2b
  • PEG-Intron™
Drug: Ribavirin
Other Names:
  • Rebetol
  • Virin
  • Ribavrin
Active Comparator: 2
  1. Pegylated IFN- alpha 2b
  2. Ribavirin for 36 weeks (patients with complete EVR)
Drug: Pegylated IFN- alpha 2b
Other Names:
  • PEG-IFN alpha-2b
  • PEG-Intron™
Drug: Ribavirin
Other Names:
  • Rebetol
  • Virin
  • Ribavrin
Active Comparator: 3
  1. Pegylated IFN- alpha 2b
  2. Ribavirin for 48 weeks (patients with partial EVR)
Drug: Pegylated IFN- alpha 2b
Other Names:
  • PEG-IFN alpha-2b
  • PEG-Intron™
Drug: Ribavirin
Other Names:
  • Rebetol
  • Virin
  • Ribavrin
Active Comparator: 4
  1. Pegylated IFN- alpha 2b
  2. Ribavirin for 48 weeks (control)
Drug: Pegylated IFN- alpha 2b
Other Names:
  • PEG-IFN alpha-2b
  • PEG-Intron™
Drug: Ribavirin
Other Names:
  • Rebetol
  • Virin
  • Ribavrin

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.

  Eligibility

Ages Eligible for Study:   18 Years to 55 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00277862

Locations
Egypt
AUS Specialized Hospital,
Cairo;, Cairo,, Egypt, 11351,
DIACSERA
Cairo, Egypt
MISR Welding
Cairo, Egypt
ELectricity Auth
Mynia and Cairo, Egypt
Sponsors and Collaborators
Ain Shams University
Schering-Plough
Fulbright
TEMPUS
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
  More Information

Publications:
Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Dr. Nelly Sedky, Dr. Gehan Galal, DIAGSERA
ClinicalTrials.gov Identifier: NCT00277862     History of Changes
Other Study ID Numbers: G43230832638
Study First Received: January 15, 2006
Last Updated: February 25, 2008
Health Authority: United States: Institutional Review Board

Keywords provided by Ain Shams University:
chronic hepatitis C;
peg-interferon alfa-2b;
ribavirin,
rapid virologic response,
sustained virological response

Additional relevant MeSH terms:
Hepatitis
Hepatitis A
Hepatitis C
Hepatitis, Chronic
Digestive System Diseases
Enterovirus Infections
Flaviviridae Infections
Hepatitis, Viral, Human
Liver Diseases
Picornaviridae Infections
RNA Virus Infections
Virus Diseases
Interferon-alpha
Ribavirin
Anti-Infective Agents
Antimetabolites
Antiviral Agents
Immunologic Factors
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Physiological Effects of Drugs
Therapeutic Uses

ClinicalTrials.gov processed this record on May 21, 2015