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

Hepatitis C Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00527540
• Other study ID #: THC-10
• Status: Completed
• Phase: Phase 3
• First received: September 8, 2007
• Last updated: January 18, 2009
• Start date: February 2007
• Est. completion date: December 2008

Study information

• Verified date: January 2009
• Source: Tehran Hepatitis Center
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 60
• Est. completion date: December 2008
• Est. primary completion date: June 2008
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Hepatitis
• Hepatitis A
• Hepatitis C
• Hepatitis C, Chronic
• Hepatitis, Chronic

Intervention

Drug:
• Pegylated Interferon alpha 2a + Ribavirin
Pegaferon: Ampule, 180 microgram per week Ribaverin: Tablet, 10-15 mg/kg per day

Locations

Country	Name	City	State
Iran, Islamic Republic of	Tehran Hepatitis Center	Tehran

Sponsors (2)

Lead Sponsor	Collaborator
Tehran Hepatitis Center	Kermanshah University of Medical Sciences

Country where clinical trial is conducted

Iran, Islamic Republic of, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	End of treatment response rate (HCV RNA:Neg)		End of treatment course
Secondary	Sustain response rate (HCV RNA:Neg) 6 month after end of treatment		6 month after end of treatment