NCT00527540

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.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
60

participants targeted

Target at below P25 for phase_3

Timeline
Completed

Started Feb 2007

Geographic Reach
1 country

1 active site

Status
completed

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

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

February 1, 2007

Completed
7 months until next milestone

First Submitted

Initial submission to the registry

September 8, 2007

Completed
3 days until next milestone

First Posted

Study publicly available on registry

September 11, 2007

Completed
9 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2008

Completed
6 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2008

Completed
Last Updated

January 21, 2009

Status Verified

January 1, 2009

Enrollment Period

1.3 years

First QC Date

September 8, 2007

Last Update Submit

January 18, 2009

Conditions

Hepatitis C

Outcome Measures

Primary Outcomes (1)

  • End of treatment response rate (HCV RNA:Neg)

    End of treatment course

Secondary Outcomes (1)

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

    6 month after end of treatment

Interventions

Pegylated Interferon alpha 2a + RibavirinDRUG

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

Also known as: Pegaferon

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

  • 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
  • +14 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Tehran Hepatitis Center

Tehran, Tehran Province, Iran

Location

MeSH Terms

Conditions

Hepatitis C

Interventions

Ribavirin

Condition Hierarchy (Ancestors)

Blood-Borne InfectionsCommunicable DiseasesInfectionsHepatitis, Viral, HumanVirus DiseasesFlaviviridae InfectionsRNA Virus InfectionsHepatitisLiver DiseasesDigestive System Diseases

Intervention Hierarchy (Ancestors)

RibonucleosidesNucleosidesNucleic Acids, Nucleotides, and Nucleosides

Study Officials

  • Seyed M Alavian, Prof.

    Tehran Hepatitis Center

    STUDY CHAIR

  • Behzad Hajarizadeh, MD

    Tehran Hepatitis Center

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 3
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER

Study Record Dates

First Submitted

September 8, 2007

First Posted

September 11, 2007

Study Start

February 1, 2007

Primary Completion

June 1, 2008

Study Completion

December 1, 2008

Last Updated

January 21, 2009

Record last verified: 2009-01

Locations

IR(1)