NCT00502788

Brief Summary

Hepatitis C is one of the most common causes of long-term liver disease in the United States. Ribavirin and peginterferon alfa-2a are two medications that are used to treat hepatitis C infection. The purpose of this study is to evaluate the safety of these two medications in adults with hepatitis C and thalassemia, a type of blood disorder.

Trial Health

90
On Track

Trial Health Score

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

Enrollment
21

participants targeted

Target at below P25 for phase_2

Timeline
Completed

Started May 2003

Typical duration for phase_2

Geographic Reach
3 countries

5 active sites

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, 2003

Completed
3.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2006

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2006

Completed
12 months until next milestone

First Submitted

Initial submission to the registry

July 16, 2007

Completed
2 days until next milestone

First Posted

Study publicly available on registry

July 18, 2007

Completed
Last Updated

March 4, 2014

Status Verified

March 1, 2014

Enrollment Period

3.1 years

First QC Date

July 16, 2007

Last Update Submit

March 3, 2014

Conditions

Hepatitis CThalassemia

Outcome Measures

Primary Outcomes (1)

  • Safety of peginterferon alfa-2a and ribavirin in individuals with thalassemia (measured by changes in liver iron stores and development of iron overload-related complications)

    Measured at Week 72

Secondary Outcomes (10)

  • Mean change in hepatic iron concentration from baseline biopsy to follow-up biopsy; relationship of change to baseline level

    Measured at Week 48

  • Transfusion frequency and volume required to maintain trough Hb 9.0-10.5 g/dL during treatment, as compared to that required in the 6 months prior to hepatitis C treatment

    Measured at Week 72

  • Cumulate change in deferoxamine dose; evidence for deferoxamine toxicity during hepatitis C treatment

    Measured at Week 72

  • Response rate (undetectable hepatitis C virus RNA)

    Measured at Week 24 or 48

  • Sustained virologic response rate (undetectable hepatitis C virus RNA 24 weeks after the end of treatment) and its association with baseline hepatic iron concentration

    Measured at Week 72

  • +5 more secondary outcomes

Interventions

Peginterferon Alfa-2a and RibavirinDRUG

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.

Also known as: Human recombinant E. Coli, Hoffmann-la Roche
RibavirinDRUG

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.

Eligibility Criteria

Age18 Years - 44 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • Diagnosis of thalassemia
  • 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

You may not qualify if:

  • Baseline liver iron concentration greater than 40.00 mg/g dry weight (iron may be chelated and the individual re-screened). All people with liver iron levels greater than 20.00 mg/g dry weight will be permitted to enroll only if their ejection fraction is 55 or greater by echocardiography (ECHO).
  • 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)
  • +14 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (5)

Children's Hospital and Research Center at Oakland

Oakland, California, 94609, United States

Location

Weill Medical College of Cornell University

New York, New York, 10021, United States

Location

Children's Hospital Philadelphia

Philadelphia, Pennsylvania, 19104, United States

Location

Toronto General Hospital, Universty Health Network

Toronto, Ontario, M5G 2C4, Canada

Location

University College London

London, WC1E 6HX, United Kingdom

Location

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

  • Maureen Jonas, MD

    Boston Children's Hospital

    STUDY CHAIR

Study Design

Study Type
interventional
Phase
phase 2
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Expanded Access
Yes

Study Record Dates

First Submitted

July 16, 2007

First Posted

July 18, 2007

Study Start

May 1, 2003

Primary Completion

June 1, 2006

Study Completion

August 1, 2006

Last Updated

March 4, 2014

Record last verified: 2014-03

Locations

CA(1)US(3)GB(1)