MedDataX Logo

Pegasys® Plus Ribavirin in Thalassemic Patients With Hepatitis C Virus Infection

NCT ID: NCT00707850

Last Updated: 2010-08-31

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Clinical Phase

PHASE4

Total Enrollment

300 participants

Study Classification

INTERVENTIONAL

Study Start Date

2007-05-31

Study Completion Date

2009-09-30

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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.

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

Patients with Thalassemia receive chronic blood transfusions and have an increased prevalence of chronic Hepatitis C virus (HCV) infection, particularly if transfused before HCV serological testing became available. The investigators enrolled 300 patients into the study. The patients received PEGASYS (Peginterferon alpha-2a(40 KD)) 180 microgram per week plus COPEGUS (Ribavirin) 1000 milligram for weight less than or equal 75 kg and 1200 milligram for more than 75 kg for 48 weeks. Follow up period is 6 months after treatment. The patients are visited every 4 weeks with biochemistry lab tests. The patients are checked with quantitative HCV RNA (Ribonucleic Acid) on the third months 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.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Hepatitis C Thalassemia

Keywords

Explore important study keywords that can help with search, categorization, and topic discovery.

Hepatitis C Thalassemia Pegasys Ribavirin

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

NON_RANDOMIZED

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

1

Thalassemic Patients with HCV

Group Type EXPERIMENTAL

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

Intervention Type DRUG

PEGASYS: 180 microgram per week (Injection) Plus Ribavirin: \[=\<75 kg: 1000 mg; \>75 kg: 1200 mg per day (PO)\]

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

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

PEGASYS: 180 microgram per week (Injection) Plus Ribavirin: \[=\<75 kg: 1000 mg; \>75 kg: 1200 mg per day (PO)\]

Intervention Type DRUG

Other Intervention Names

Discover alternative or legacy names that may be used to describe the listed interventions across different sources.

Peginterferon Alfa-2a (40KD) plus COPEGUS

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

Inclusion Criteria

* HCV RNA positive
* Age older than 12 years

Exclusion Criteria

* 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)
Minimum Eligible Age

12 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

Baqiyatallah Research Center for Gastroenterology and Liver Diseases

OTHER

Sponsor Role collaborator

Tehran Hepatitis Center

OTHER

Sponsor Role collaborator

Guilan University of Medical Sciences

OTHER

Sponsor Role collaborator

Tabriz Research Center for Gastroenterology and Liver Diseases

UNKNOWN

Sponsor Role collaborator

Baqiyatallah Medical Sciences University

OTHER

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Baqiyatallah Research Center for Gastroenterology and Liver Diseases

Principal Investigators

Learn about the lead researchers overseeing the trial and their institutional affiliations.

Seyed-Moayed Alavian, Professor

Role: STUDY_CHAIR

Baqiyatallah Research Center for Gastroenterology and Liver Disea

Seyyed Mohammad Miri, M.D.

Role: STUDY_DIRECTOR

Baqiyatallah Research Center for Gastroenterology and Liver Disea

Pegah Karimi, M.D.

Role: PRINCIPAL_INVESTIGATOR

Baqiyatallah Research Center for Gastroenterology and Liver Diseases

Maryam Keshvari, M.D.

Role: PRINCIPAL_INVESTIGATOR

Iranian blood Transfusion Research Center

Bita Behnava, M.D.

Role: PRINCIPAL_INVESTIGATOR

Baqiyatallah Research Center for Gastroenterology and Liver Diseases

Mohammad Hossein Somi, M.D.

Role: PRINCIPAL_INVESTIGATOR

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

Fariborz Mansour-Ghanaei, M.D.

Role: PRINCIPAL_INVESTIGATOR

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

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

Baqiyatallah Research Center for Gastroenterology and Liver Diseases

Tehran, Tehran Province, Iran

Site Status

Countries

Review the countries where the study has at least one active or historical site.

Iran

References

Explore related publications, articles, or registry entries linked to this study.

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.

Reference Type BACKGROUND
PMID: 18556414 (View on PubMed)

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

BRCGL-08-06

Identifier Type: -

Identifier Source: org_study_id