NCT00707772

Brief Summary

Hemophilic patients are a known high risk groups for acquiring the hepatitis C. The surveillance data from Ministry Of Health in IR.Iran had shown that 60% of them are infected with HCV infection. We are trying the PEGASYS plus Ribavirin in Hemophilic patients with HCV.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
400

participants targeted

Target at P75+ for phase_4

Timeline
Completed

Started Mar 2007

Typical duration for phase_4

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

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

March 1, 2007

Completed
1.3 years until next milestone

First Submitted

Initial submission to the registry

June 26, 2008

Completed
5 days until next milestone

First Posted

Study publicly available on registry

July 1, 2008

Completed
1.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2009

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2009

Completed
Last Updated

September 17, 2009

Status Verified

September 1, 2009

Enrollment Period

2.5 years

First QC Date

June 26, 2008

Last Update Submit

September 16, 2009

Conditions

Hepatitis CHemophilia

Keywords

Hepatitis CHemophiliaPegasysRibavirin

Outcome Measures

Primary Outcomes (4)

  • Early Virologic Response

    After 12 weeks of Treatment

  • End of Treatment Response

    24 weeks for : Genotype 2 & 3; 48 Weeks for other genotype

  • Sustained Virologic Response

    24 weeks after Treatment

  • Rapid Virologic Response

    One month after Treatment

Secondary Outcomes (3)

  • Tolerability of drugs for whole therapy period

    During Treatment

  • Biochemical response (ALT)

    End of Treatment AND 24 weeks after Treatment

  • Laboratory Parameters

    During Treatment AND End of treatment

Study Arms (2)

1

ACTIVE COMPARATOR

Genotype 2 or 3 in Hemophilic Patients with HCV

Drug: PEGASYS® (Peginterferon Alfa-2a (40KD)) Plus COPEGUS® (Ribavirin)

2

ACTIVE COMPARATOR

Other Genotypes (except 2 or 3) in Hemophilic Patients with HCV

Drug: PEGASYS® (Peginterferon Alfa-2a (40KD)) Plus COPEGUS® (Ribavirin)

Interventions

PEGASYS® (Peginterferon Alfa-2a (40KD)) Plus COPEGUS® (Ribavirin)DRUG

PEGASYS: 180 microgram per week (Injection) Plus Ribavirin: 800 milligram per day (PO)

Also known as: Peginterferon Alfa-2a (40KD) Plus COPEGUS
1

Eligibility Criteria

Age12 Years+
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • HCV RNA positive
  • Age older than 12 years

You may not qualify if:

  • Ongoing pregnancy or breast feeding
  • Hx of HCC
  • Hx of alcoholic liver disease
  • Hx of bleeding from esophageal varices
  • Hx of hemochromatosis
  • Hx of autoimmune hepatitis
  • Hx of Suicidal attempt
  • Hx of cerebrovascular dis
  • Hx of severe retinopathy
  • Hx of severe psoriasis
  • Hx of scleroderma
  • Hx of metabolic liver disease
  • Hx of SLE

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Baqiyatallah Research Center for Gastroenterology and Liver Diseases

Tehran, Tehran Province, 14155-3651, Iran

Location

Related Publications (1)

  • Iafolla M. [Pegasys: FDA approved Pegasys (peginterferon alfa-2a) for the treatment of hepatitis C]. Sidahora. 2002;(4):8-10. No abstract available. Spanish.

    PMID: 12703472BACKGROUND

MeSH Terms

Conditions

Hepatitis CHemophilia A

Interventions

peginterferon alfa-2aRibavirin

Condition Hierarchy (Ancestors)

Blood-Borne InfectionsCommunicable DiseasesInfectionsHepatitis, Viral, HumanVirus DiseasesFlaviviridae InfectionsRNA Virus InfectionsHepatitisLiver DiseasesDigestive System DiseasesBlood Coagulation Disorders, InheritedBlood Coagulation DisordersHematologic DiseasesHemic and Lymphatic DiseasesCoagulation Protein DisordersHemorrhagic DisordersGenetic Diseases, InbornCongenital, Hereditary, and Neonatal Diseases and Abnormalities

Intervention Hierarchy (Ancestors)

RibonucleosidesNucleosidesNucleic Acids, Nucleotides, and Nucleosides

Study Officials

  • Professor Seyed-Moayed Alavian, Professor

    Baqiyatallah Research Center for Gastroenterology and Liver Diseases

    STUDY CHAIR

  • Seyyed Mohammad Miri, M.D.

    Baqiyatallah Research Center for Gastroenterology and Liver Diseases

    STUDY DIRECTOR

  • Maryam Keshvari, M.D.

    Iranian blood Transfusion Research Center

    PRINCIPAL INVESTIGATOR

  • Bita Behnava, M.D.

    Baqiyatallah Research Center for Gastroenterology and Liver Diseases

    PRINCIPAL INVESTIGATOR

  • Mohammad Hossein Somi, M.D.

    Research Center for Gastroenterology and Hepatology, Tabriz University of Medical Sciences, Tabriz

    PRINCIPAL INVESTIGATOR

  • Fariborz Mansour-Ghanaei, M.D.

    Gastroenterology and Liver Diseases, Gastrointestinal and Liver Diseases Research Center (GLDRC), Guilan University of Medical Sciences, Rasht, Iran

    PRINCIPAL INVESTIGATOR

  • Pegah Karimi, M.D.

    Baqiyatallah Research Center for Gastroenterology and Liver Diseases

    PRINCIPAL INVESTIGATOR

  • Bashir HajiBeigi, M.D.

    Iranian Blood Transfusion Research Center

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 4
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER

Study Record Dates

First Submitted

June 26, 2008

First Posted

July 1, 2008

Study Start

March 1, 2007

Primary Completion

September 1, 2009

Study Completion

September 1, 2009

Last Updated

September 17, 2009

Record last verified: 2009-09

Locations

IR(1)