Pegylated Interferon and Ribavirin Therapy in Chronic Hepatitis Genotype 4

NCT00277862 | Completed Phase 4 DMC

• 1 other identifier: G43230832638
• Study Type: interventional
• Target: 280
• Locations: 1 country
• Sites: 4

Brief 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

Keywords

chronic hepatitis C;; peg-interferon alfa-2b;; ribavirin,; rapid virologic response,; sustained virological response

Outcome Measures

Primary Outcomes (1)

• sustained virologic response defined as undetectable serum HCV RNA levels (Amplicor HCV, Roche Molecular Systems; lower limit of detection (LLD) of 50 IU/mL)

  18 months

Secondary Outcomes (2)

• 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

  6-12 months and 6 months follow-up

• sustained virologic response (primary) histological response (secondary) biochemical response (secondary)

  6-12 months treatment), 6 months follow-up

Study Arms (4)

1

ACTIVE COMPARATOR

1. Pegylated IFN- alpha 2b 2. Ribavirin for 24 weeks (patients with RVR)

Drug: Pegylated IFN- alpha 2b; Drug: Ribavirin

2

ACTIVE COMPARATOR

1. Pegylated IFN- alpha 2b 2. Ribavirin for 36 weeks (patients with complete EVR)

Drug: Pegylated IFN- alpha 2b; Drug: Ribavirin

3

ACTIVE COMPARATOR

1. Pegylated IFN- alpha 2b 2. Ribavirin for 48 weeks (patients with partial EVR)

Drug: Pegylated IFN- alpha 2b; Drug: Ribavirin

4

ACTIVE COMPARATOR

1. Pegylated IFN- alpha 2b 2. Ribavirin for 48 weeks (control)

Drug: Pegylated IFN- alpha 2b; Drug: Ribavirin

Interventions

Pegylated IFN- alpha 2b DRUG

Also known as: PEG-IFN alpha-2b, PEG-Intron™

1; 2; 3; 4

Ribavirin DRUG

Also known as: Rebetol, Virin, Ribavrin

1; 2; 3; 4

Eligibility Criteria

• Age: 18 Years - 55 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may not qualify if:

• 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.

Sponsors & Collaborators

• Ain Shams University: lead
• Schering-Plough: collaborator
• Fulbright: collaborator
• Tempus AI: collaborator
• International Society for Infectious Diseases: collaborator

Study Sites (4)

AUS Specialized Hospital,

Cairo, Cairo Governorate, 11351,, Egypt

Location

DIACSERA

Cairo, Egypt

Location

MISR Welding

Cairo, Egypt

Location

ELectricity Auth

Mynia and Cairo, Egypt

Location

Related Publications (3)

• Kamal SM, El Tawil AA, Nakano T, He Q, Rasenack J, Hakam SA, Saleh WA, Ismail A, Aziz AA, Madwar MA. Peginterferon alpha-2b and ribavirin therapy in chronic hepatitis C genotype 4: impact of treatment duration and viral kinetics on sustained virological response. Gut. 2005 Jun;54(6):858-66. doi: 10.1136/gut.2004.057182.

  PMID: 15888797 BACKGROUND

• Kamal SM, Fehr J, Roesler B, Peters T, Rasenack JW. Peginterferon alone or with ribavirin enhances HCV-specific CD4 T-helper 1 responses in patients with chronic hepatitis C. Gastroenterology. 2002 Oct;123(4):1070-83. doi: 10.1053/gast.2002.36045.

  PMID: 12360469 BACKGROUND

• Kamal SM, El Kamary SS, Shardell MD, Hashem M, Ahmed IN, Muhammadi M, Sayed K, Moustafa A, Hakem SA, Ibrahiem A, Moniem M, Mansour H, Abdelaziz M. Pegylated interferon alpha-2b plus ribavirin in patients with genotype 4 chronic hepatitis C: The role of rapid and early virologic response. Hepatology. 2007 Dec;46(6):1732-40. doi: 10.1002/hep.21917.

  PMID: 17943989 DERIVED

MeSH Terms

Conditions

Hepatitis C; Hepatitis C, Chronic

Interventions

peginterferon alfa-2b; Ribavirin

Condition Hierarchy (Ancestors)

Blood-Borne Infections; Communicable Diseases; Infections; Hepatitis, Viral, Human; Virus Diseases; Flaviviridae Infections; RNA Virus Infections; Hepatitis; Liver Diseases; Digestive System Diseases; Hepatitis, Chronic; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Ribonucleosides; Nucleosides; Nucleic Acids, Nucleotides, and Nucleosides

Study Officials

• 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

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: January 15, 2006
• First Posted: January 18, 2006
• Study Start: April 1, 2002
• Primary Completion: March 1, 2007
• Study Completion: April 1, 2007
• Last Updated: February 26, 2008

Record last verified: 2008-02

Locations

EG (4)