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Effectiveness and Side Effects of Pegylated Interferon Alpha-2a (Pegaferon®) Plus Ribavirin in the Patients With Chronic Hepatitis C

Primary Purpose

Hepatitis C

Status
Completed
Phase
Phase 3
Locations
Iran, Islamic Republic of
Study Type
Interventional
Intervention
Pegylated Interferon alpha 2a + Ribavirin
Sponsored by
Tehran Hepatitis Center
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional treatment trial for Hepatitis C

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • HCV RNA: Positive
  • Biopsy approved in genotype 1
  • Age older than 18 yrs

Exclusion Criteria:

  • ongoing pregnancy or breast feeding
  • Hx of hemochromatosis
  • Hx of metabolic liver dis.
  • Hx of HCC
  • Hx of autoimmune hepatitis
  • Hx of alcoholic liver dis.
  • Hx of bleeding from esophageal varices
  • ongoing systemic anti-viral or anti-neoplasmic treatment
  • Hx of treatment with an anti-depressant medication at therapeutic doses for at least 3 months at any pervious time
  • Hx of treatment with an tranquilizer at therapeutic doses for psychosis for at least 3 months at any pervious time
  • Hx of hospitalization for psychiatric dis.
  • Hx of suicidal attempt
  • Hx of IBD
  • Hx of SLE
  • Hx of scleroderma
  • Hx of rheumatoid arthritis
  • Hx of ITP
  • Hx of autoimmune hemolytic anemia
  • Hx of severe psoriasis
  • Hx of chronic pulmonary dis. associated with functional limitation
  • Hx of MI or unstable angina
  • Hx of arrhythmia requiring ongoing treatment
  • Hx of functional class III or IV
  • Hx of severe seizure dis. or current anti-convulsant use
  • Hx of organ transplantation with existing functional graft
  • Hx of severe retinopathy
  • Hx of Thalassemia
  • Hx of spherocytosis
  • Hx of cerebrovascular dis.

Sites / Locations

  • Tehran Hepatitis Center

Outcomes

Primary Outcome Measures

End of treatment response rate (HCV RNA:Neg)

Secondary Outcome Measures

Sustain response rate (HCV RNA:Neg) 6 month after end of treatment

Full Information

First Posted
September 8, 2007
Last Updated
January 18, 2009
Sponsor
Tehran Hepatitis Center
Collaborators
Kermanshah University of Medical Sciences
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1. Study Identification

Unique Protocol Identification Number
NCT00527540
Brief Title
Effectiveness and Side Effects of Pegylated Interferon Alpha-2a (Pegaferon®) Plus Ribavirin in the Patients With Chronic Hepatitis C
Official Title
Effectiveness and Side Effects of Pegylated Interferon Alpha-2a (Pegaferon®) Plus Ribavirin in the Patients With Chronic Hepatitis C
Study Type
Interventional

2. Study Status

Record Verification Date
January 2009
Overall Recruitment Status
Completed
Study Start Date
February 2007 (undefined)
Primary Completion Date
June 2008 (Actual)
Study Completion Date
December 2008 (Actual)

3. Sponsor/Collaborators

Name of the Sponsor
Tehran Hepatitis Center
Collaborators
Kermanshah University of Medical Sciences

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

Brief Summary
Pegylation of interferon prolongs the medication half-life which has resulted in Pegylated Interferon (PEG-IFN) as the new modality for treatment of chronic hepatitis C. We current this clinical trial to assess the efficacy and safety of domestic PEG-IFN alpha-2a (Pegaferon®) in the patients with chronic hepatitis C.
Detailed Description
We enroll 50 patients in to the study. The patients receive Pegaferon® 180 micgr per week plus ribavirin 10-15mg/kg per day. The patients are visited every 4 weeks with biochemistry lab tests. They are checked with quantitative HCV PCR on the third month after initiation of the treatment to assess early virologic response and at the end of the study for complete response rate and on the six month after treatment completion for sustained response rate. The patients with undetectable HCV RNA are considered as responders.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Hepatitis C

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
60 (Anticipated)

8. Arms, Groups, and Interventions

Intervention Type
Drug
Intervention Name(s)
Pegylated Interferon alpha 2a + Ribavirin
Other Intervention Name(s)
Pegaferon
Intervention Description
Pegaferon: Ampule, 180 microgram per week Ribaverin: Tablet, 10-15 mg/kg per day
Primary Outcome Measure Information:
Title
End of treatment response rate (HCV RNA:Neg)
Time Frame
End of treatment course
Secondary Outcome Measure Information:
Title
Sustain response rate (HCV RNA:Neg) 6 month after end of treatment
Time Frame
6 month after end of treatment

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: HCV RNA: Positive Biopsy approved in genotype 1 Age older than 18 yrs Exclusion Criteria: ongoing pregnancy or breast feeding Hx of hemochromatosis Hx of metabolic liver dis. Hx of HCC Hx of autoimmune hepatitis Hx of alcoholic liver dis. Hx of bleeding from esophageal varices ongoing systemic anti-viral or anti-neoplasmic treatment Hx of treatment with an anti-depressant medication at therapeutic doses for at least 3 months at any pervious time Hx of treatment with an tranquilizer at therapeutic doses for psychosis for at least 3 months at any pervious time Hx of hospitalization for psychiatric dis. Hx of suicidal attempt Hx of IBD Hx of SLE Hx of scleroderma Hx of rheumatoid arthritis Hx of ITP Hx of autoimmune hemolytic anemia Hx of severe psoriasis Hx of chronic pulmonary dis. associated with functional limitation Hx of MI or unstable angina Hx of arrhythmia requiring ongoing treatment Hx of functional class III or IV Hx of severe seizure dis. or current anti-convulsant use Hx of organ transplantation with existing functional graft Hx of severe retinopathy Hx of Thalassemia Hx of spherocytosis Hx of cerebrovascular dis.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Seyed M Alavian, Prof.
Organizational Affiliation
Tehran Hepatitis Center
Official's Role
Study Chair
First Name & Middle Initial & Last Name & Degree
Behzad Hajarizadeh, MD
Organizational Affiliation
Tehran Hepatitis Center
Official's Role
Principal Investigator
Facility Information:
Facility Name
Tehran Hepatitis Center
City
Tehran
Country
Iran, Islamic Republic of

12. IPD Sharing Statement

Learn more about this trial

Effectiveness and Side Effects of Pegylated Interferon Alpha-2a (Pegaferon®) Plus Ribavirin in the Patients With Chronic Hepatitis C

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