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Completed

NCT Number: NCT00527540

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

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.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

Tehran Hepatitis Center

Tehran, Tehran Province, Iran

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Pegylated Interferon alpha 2a + Ribavirin

Drug

Pegaferon: Ampule, 180 microgram per week Ribaverin: Tablet, 10-15 mg/kg per day

Other names: Pegaferon

Primary outcomes

  1. End of treatment response rate (HCV RNA:Neg)

    Time frame: End of treatment course

Secondary outcomes

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

    Time frame: 6 month after end of treatment

Sponsors and collaborators

Lead sponsor

Tehran Hepatitis Center

Other

Collaborators

  • Kermanshah University of Medical Sciences

Registry information

Important dates

Study start
2007
Primary completion
2008
Study completion
2008
First posted
Sep 11, 2007
Registry last updated
Jan 21, 2009

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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