Evaluating the Safety of Two Medications to Treat Hepatitis C in People With Thalassemia (The HepC Study)
NCT ID: NCT00502788
Last Updated: 2014-03-04
Study Results
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.
COMPLETED
PHASE2
21 participants
INTERVENTIONAL
2003-05-31
2006-08-31
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
Related Clinical Trials
Explore similar clinical trials based on study characteristics and research focus.
Interferon and Ribavirin Treatment in Patients With Hemoglobinopathies
NCT00887081
Thalidomide Plus Peginterferon and Ribavirin in Patients With Interferon Resistance
NCT00856804
Low-Dose Peginterferon and Ribavirin to Treat Chronic Hepatitis C in Patients Infected With HCV Genotype 2 or 3
NCT00056862
Treatment of Chronic Hepatitis C With PEG Interferon alfa2a and Ribavirin in HIV-Infected Patients
NCT00221650
Relapse Rate in Hepatitis C Patients Treated With Peginterferon Alfa-2b Plus Ribavirin in Common Clinical Practice in France (P05484)(Completed)
NCT00725842
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
This study will enroll adults with thalassemia and long-term hepatitis C. Participants will attend study visits weekly for 4 weeks, every 2 weeks until Week 24, every 4 weeks until Week 48, and then every 6 weeks until Week 72. All participants will receive a peginterferon alfa-2a injection once a week and ribavirin daily. Participants with the hepatitis C genotype 1 will receive 48 weeks of treatment; participants with all other genotypes of the disease will receive 24 weeks of treatment. A liver biopsy will occur at baseline and Week 48. The following will occur at selected study visits: physical exam, blood and urine collection, hearing and vision screening, chest x-ray, heart rate monitoring, and questionnaires to assess hepatitis C symptoms, quality of life, and depression. Participants with liver iron levels greater than 20 mg/g will undergo an echocardiogram ultrasound test every 3 months to monitor the heart.
Conditions
See the medical conditions and disease areas that this research is targeting or investigating.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
NON_RANDOMIZED
SINGLE_GROUP
TREATMENT
NONE
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
Peginterferon Alfa-2a and Ribavirin
Patients will be treated with alfa-2a and ribavirin as follows:
Peginterferon alfa-2a will be started as a dose of 180 ug subcutaneously once weekly.
Ribavirin
Ribavirin will be started at a dose of 800mg daily for those weighing less than or equal to 50 kg, 1000 mg daily for those with body weight 51 to 75 kg and 1200 mg daily for those with body weight \> 75 kg. Ribavirin will be given orally in two divided doses. The lower dose has been included because potentially-eligible patients in the TCRN registry have a mean weight of 57 kg.
Other Intervention Names
Discover alternative or legacy names that may be used to describe the listed interventions across different sources.
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
* Serum positive for hepatitis C virus RNA by polymerase chain reaction (PCR) test (using the Roche COBAS Amplicor hepatitis C virus test)
* Hepatitis B surface antigen (HBsAg) negative and HIV negative within the 12 months prior to study entry
* Liver biopsy showing histologic evidence of active hepatitis (i.e., at least grade 1 inflammation)
* Willing to use acceptable forms of contraception throughout the study
Exclusion Criteria
* Currently participating in other interventional clinical studies
* Received interferon-alfa therapy within the 6 months prior to study entry
* Liver dysfunction, defined as international normalized ratio (INR) greater than 1.3, albumin less than or equal to 3.5g/dL, or serum bilirubin greater than 4.0 mg/dL that, in the opinion of the investigator, is not due to Gilbert's syndrome or thalassemia-related hemolysis
* Other causes of liver disease (e.g., hereditary hemochromatosis, presumed drug-associated liver disease, Wilson's disease, obesity \[body mass index (BMI) greater than 30\])
* Major psychiatric illness
* Neutrophil count less than or equal to 1500/mm3
* Platelet count less than or equal to 80,000/mm3
* Active alcohol abuse within the 12 months prior to study entry
* Use of illicit drugs (e.g., heroin, cocaine, angel dust) within the 2 years prior to study entry
* Alpha-fetoprotein level greater than 200 ng/mL or evidence of a liver mass lesion by either ultrasound, CT scan, or MRI scan that is suspicious for hepatocellular cancer
* Kidney insufficiency, as defined by a clinically significant abnormal serum creatinine test and confirmed by a creatinine clearance rate of less than 50 mL/min based on 24-hour urine collection. People with an elevated serum creatinine level must undergo a creatinine clearance test.
* Diabetes that, in the opinion of the investigator, is not controlled by diet, an oral hypoglycemic agent, and/or insulin
* Received an organ, limb, or bone marrow transplant
* Requires the use of certain long-term medications such as immunosuppressive medications (e.g., corticosteroids, methotrexate, azathioprine)
* Active systemic autoimmune disorder (e.g., rheumatoid arthritis, systemic lupus)
* Diagnosis or treatment of cancer within the 5 years prior to study entry, except for localized squamous or basal cell cancers treated by local excision
* Any of the following pre-existing conditions that, in the opinion of the investigator, would prevent treatment with interferon and/or ribavirin:
1. unstable heart disease that is not controlled by medication
2. serious cerebrovascular disease
3. serious lung disease
* History of a seizure disorder that has not been well-controlled by anti-seizure medications within the 2 years prior to study entry
* Pregnant or breastfeeding
* Male partners of women who are pregnant
* Any other condition that, in the opinion of the investigator, would prevent study participation
* Known hypersensitivity to any study drug or their components
* Past history of multiple sclerosis, transverse myelitis, optic neuritis, papilledema, chorioretinitis, uveitis, or increased ocular pressure/glaucoma
* Currently taking hematopoietic growth factors
* Currently taking ribavirin
18 Years
44 Years
ALL
No
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
National Heart, Lung, and Blood Institute (NHLBI)
NIH
Carelon Research
OTHER
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
National Institutes of Health
Principal Investigators
Learn about the lead researchers overseeing the trial and their institutional affiliations.
Maureen Jonas, MD
Role: STUDY_CHAIR
Boston Children's Hospital
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
Children's Hospital and Research Center at Oakland
Oakland, California, United States
Weill Medical College of Cornell University
New York, New York, United States
Children's Hospital Philadelphia
Philadelphia, Pennsylvania, United States
Toronto General Hospital, Universty Health Network
Toronto, Ontario, Canada
University College London
London, , United Kingdom
Countries
Review the countries where the study has at least one active or historical site.
Other Identifiers
More Related Trials
Additional clinical trials that may be relevant based on similarity analysis.