NCT00707850

Brief Summary

Antiviral treatment of HCV in thalassemia has raised concerns of ribavirin-induced hemolysis and increased iron loading. Blood Transfusion in Thalassemic patients are a known high risk for acquiring hepatitis C. The investigators are trying the PEGASYS (Peginterferon alpha-2a(40 KD)) plus Ribavirin in Thalassemic patients with HCV.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
300

participants targeted

Target at P75+ for phase_4

Timeline
Completed

Started May 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

May 1, 2007

Completed
1.2 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

August 31, 2010

Status Verified

September 1, 2009

Enrollment Period

2.3 years

First QC Date

June 26, 2008

Last Update Submit

August 30, 2010

Conditions

Hepatitis CThalassemia

Keywords

Hepatitis CThalassemiaPegasysRibavirin

Outcome Measures

Primary Outcomes (4)

  • Early Virologic Response

    After 12 weeks of Treatment

  • End of Treatment Response

    48 Weeks

  • 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 (1)

1

EXPERIMENTAL

Thalassemic 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: \[=\<75 kg: 1000 mg; \>75 kg: 1200 mg per day (PO)\]

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
  • History (Hx) of Hepatocellular Carcinoma (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 Systemic Lupus Erythematosus (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)

  • Harmatz P, Jonas MM, Kwiatkowski JL, Wright EC, Fischer R, Vichinsky E, Giardina PJ, Neufeld EJ, Porter J, Olivieri N; Thalassemia Clinical Research Network. Safety and efficacy of pegylated interferon alpha-2a and ribavirin for the treatment of hepatitis C in patients with thalassemia. Haematologica. 2008 Aug;93(8):1247-51. doi: 10.3324/haematol.12352. Epub 2008 Jun 12.

    PMID: 18556414BACKGROUND

MeSH Terms

Conditions

Hepatitis CThalassemia

Interventions

peginterferon alfa-2aRibavirin

Condition Hierarchy (Ancestors)

Blood-Borne InfectionsCommunicable DiseasesInfectionsHepatitis, Viral, HumanVirus DiseasesFlaviviridae InfectionsRNA Virus InfectionsHepatitisLiver DiseasesDigestive System DiseasesAnemia, Hemolytic, CongenitalAnemia, HemolyticAnemiaHematologic DiseasesHemic and Lymphatic DiseasesHemoglobinopathiesGenetic Diseases, InbornCongenital, Hereditary, and Neonatal Diseases and Abnormalities

Intervention Hierarchy (Ancestors)

RibonucleosidesNucleosidesNucleic Acids, Nucleotides, and Nucleosides

Study Officials

  • Seyed-Moayed Alavian, Professor

    Baqiyatallah Research Center for Gastroenterology and Liver Disea

    STUDY CHAIR

  • Seyyed Mohammad Miri, M.D.

    Baqiyatallah Research Center for Gastroenterology and Liver Disea

    STUDY DIRECTOR

  • Pegah Karimi, M.D.

    Baqiyatallah Research Center for Gastroenterology and Liver Diseases

    PRINCIPAL INVESTIGATOR

  • 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

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

May 1, 2007

Primary Completion

September 1, 2009

Study Completion

September 1, 2009

Last Updated

August 31, 2010

Record last verified: 2009-09

Locations

IR(1)