NCT00502099

Brief Summary

Genotype 4 hepatitis C virus is the cause of approximately 20% of the 170 million cases of chronic hepatitis C in the world. Although rare in western nations, genotype 4 is the most common variant of the hepatitis C virus in Egypt and is also found throughout Africa and the Middle East. Early reports on the treatment of patients with genotype 4 chronic hepatitis C with interferon-alfa (IFN)-alfa monotherapy indicate poor rates of sustained viral response (SVR). With the introduction of ribavirin combination therapy and with pegylation of the IFN alfa molecule, however, response rates have improved dramatically, and current clinical trial data indicate that SVR rates between 43 and 79% are attainable in genotype 4 patients who are receiving pegylated IFN alfa plus ribavirin for 48 weeks. Clinical advances to optimize treatment for each patient have also been made, and tailored treatment options are now being developed that are comparable to the treatment approaches for genotype 1, 2, and 3 patients. A treatment duration of between 36 and 48 weeks appears to be optimal for most patients with chronic hepatitis C genotype 4.The aim of this study is to assess the efficacy and safety of pegylated interferon alpha 2a in patients with chronic hepatitis C genotype 4 in comparison to a historical cohort of patients treated with pegylated interferon alpha 2b

Trial Health

100
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
217

participants targeted

Target at P75+ for phase_4

Timeline
Completed

Started Jan 2006

Typical duration for phase_4

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2006

Completed
1.5 years until next milestone

First Submitted

Initial submission to the registry

July 15, 2007

Completed
2 days until next milestone

First Posted

Study publicly available on registry

July 17, 2007

Completed
1.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2009

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2009

Completed
Last Updated

October 23, 2012

Status Verified

October 1, 2012

Enrollment Period

3.3 years

First QC Date

July 15, 2007

Last Update Submit

October 21, 2012

Conditions

Hepatitis C

Keywords

Chronic hepatitis Cpegylated interferon alfa-2aribavirin, rapid virologic responseearly virologic responsesustained virologic response

Outcome Measures

Primary Outcomes (1)

  • SVR, defined as undetectable serum HCV RNA

    24 weeks after discontinuation of treatment

Secondary Outcomes (2)

  • histological response

    24 weeks after completetion of therapy

  • biochemical response

    24 weeks after therapy completion

Study Arms (2)

1

ACTIVE COMPARATOR

Pegylated interferon alpha 2a plus ribavirin

Drug: Pegylated interferon alpha 2aDrug: Ribavirin

2

ACTIVE COMPARATOR

Pegylated interferon alpha 2b plus ribavirin

Drug: Pegylated interferon alpha 2 b plus ribavirin

Interventions

Pegylated interferon alpha 2aDRUG

Injections: 180 ug once per week

Also known as: Pegaesys
1
RibavirinDRUG

Tablets, 1000-1200 daily

Also known as: Viracure
1
Pegylated interferon alpha 2 b plus ribavirinDRUG

Pegylated interferon alpha 2 b injections

Also known as: PEG-Interon
2

Eligibility Criteria

Age18 Years - 60 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • Adult men and women
  • Age: 25 to 55 years with documented chronic hepatitis
  • Elevated serum alanine aminotransferase at least 2 times the upper limit of normal (40 U/L) on 2 occasions during the preceding 6 months
  • Detectable anti-HCV antibody status assessed by second-generation enzyme-linked immunosorbent assay (Roche Diagnostics, Branchburg, New Jersey); 5. Detectable HCV RNA by polymerase chain reaction (Cobas Amplicor HCV Monitor v2.0 \[Roche Diagnostics, Branchburg, New Jersey\]; lower limit of quantitation \[50 IU/mL\])
  • Infection with HCV genotype 4
  • Histologic evidence of chronic hepatitis C in a liver biopsy specimen obtained within the preceding year.

You may not qualify if:

  • Hepatitis A, hepatitis B, autoimmune hepatitis, alcoholic liver disease, drug-induced hepatitis.
  • Decompensated liver disease with a history of variceal hemorrhage, ascites, or hepatic encephalopathy.
  • Patients coinfected with schistosomiasis or human immunodeficiency virus
  • leukocyte count lower than 3000 /mm3, neutropenia (\<1500 cells/mm3), a hemoglobin level lower than 12 g/dL for women and lower than 13 g/dL for men, thrombocytopenia (\<90,000 cells/mm3), creatinine concentration 1.5 times the upper limit of normal
  • Organ transplantation
  • Neoplastic disease
  • Severe cardiac or pulmonary disease
  • Unstable thyroid dysfunction
  • Psychiatric disorder
  • Current pregnancy or breast feeding.
  • Therapy with immunomodulatory agents within the last 6 months

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related Publications (5)

  • 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: 15888797BACKGROUND

  • El-Zayadi AR, Attia M, Barakat EM, Badran HM, Hamdy H, El-Tawil A, El-Nakeeb A, Selim O, Saied A. Response of hepatitis C genotype-4 naive patients to 24 weeks of Peg-interferon-alpha2b/ribavirin or induction-dose interferon-alpha2b/ribavirin/amantadine: a non-randomized controlled study. Am J Gastroenterol. 2005 Nov;100(11):2447-52. doi: 10.1111/j.1572-0241.2005.00253.x.

    PMID: 16279899BACKGROUND

  • Diago M, Hassanein T, Rodes J, Ackrill AM, Sedarati F. Optimized virologic response in hepatitis C virus genotype 4 with peginterferon-alpha2a and ribavirin. Ann Intern Med. 2004 Jan 6;140(1):72-3. doi: 10.7326/0003-4819-140-1-200401060-00035. No abstract available.

    PMID: 14706990BACKGROUND

  • Khuroo MS, Khuroo MS, Dahab ST. Meta-analysis: a randomized trial of peginterferon plus ribavirin for the initial treatment of chronic hepatitis C genotype 4. Aliment Pharmacol Ther. 2004 Nov 1;20(9):931-8. doi: 10.1111/j.1365-2036.2004.02208.x.

    PMID: 15521839BACKGROUND

  • Kamal SM, Ahmed A, Mahmoud S, Nabegh L, El Gohary I, Obadan I, Hafez T, Ghoraba D, Aziz AA, Metaoei M. Enhanced efficacy of pegylated interferon alpha-2a over pegylated interferon and ribavirin in chronic hepatitis C genotype 4A randomized trial and quality of life analysis. Liver Int. 2011 Mar;31(3):401-11. doi: 10.1111/j.1478-3231.2010.02435.x. Epub 2011 Jan 11.

    PMID: 21281434DERIVED

MeSH Terms

Conditions

Hepatitis CHepatitis C, Chronic

Interventions

Ribavirin

Condition Hierarchy (Ancestors)

Blood-Borne InfectionsCommunicable DiseasesInfectionsHepatitis, Viral, HumanVirus DiseasesFlaviviridae InfectionsRNA Virus InfectionsHepatitisLiver DiseasesDigestive System DiseasesHepatitis, ChronicChronic DiseaseDisease AttributesPathologic ProcessesPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

RibonucleosidesNucleosidesNucleic Acids, Nucleotides, and Nucleosides

Study Officials

  • Sanaa M Kamal, M.D.; Ph.D

    Ain Shams University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
Doctor

Study Record Dates

First Submitted

July 15, 2007

First Posted

July 17, 2007

Study Start

January 1, 2006

Primary Completion

May 1, 2009

Study Completion

May 1, 2009

Last Updated

October 23, 2012

Record last verified: 2012-10