PEDS-C: Pegylated Interferon +/- Ribavirin for Children With Hepatitis C
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| ClinicalTrials.gov Identifier: NCT00100659 |
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Recruitment Status
:
Completed
First Posted
: January 5, 2005
Results First Posted
: July 1, 2013
Last Update Posted
: July 19, 2013
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Sponsor:
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Collaborator:
Roche Pharma AG
Information provided by (Responsible Party):
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
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Brief Summary:
The purpose of this study is to determine the safety and efficacy of peginterferon alfa-2a (PEG-2a) in combination with ribavirin (RV) and PEG-2a alone for the treatment of chronic hepatitis C virus (CHC) infection in children.
The purpose of this study is also to determine whether PEG-2a in combination with RV or PEG-2a alone will result in a longer response rate in children with CHC.
| Condition or disease | Intervention/treatment | Phase |
|---|---|---|
| Chronic Hepatitis C | Drug: Pegylated Interferon/ribavirin | Phase 3 |
| Study Type : | Interventional (Clinical Trial) |
| Actual Enrollment : | 114 participants |
| Allocation: | Randomized |
| Intervention Model: | Parallel Assignment |
| Masking: | Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor) |
| Primary Purpose: | Treatment |
| Official Title: | Pegylated Interferon +/- Ribavirin for Children With Hepatitis C |
| Study Start Date : | December 2004 |
| Actual Primary Completion Date : | August 2008 |
| Actual Study Completion Date : | February 2010 |
| Arm | Intervention/treatment |
|---|---|
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Active Comparator: Pegylated interferon/ribavirin
Pegasys - 180 mcg per 1.73 meter squared body surface area subcutaneously once weekly. Ribavirin - 15 mg per kg orally twice daily using 100-mg tablets. |
Drug: Pegylated Interferon/ribavirin |
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Placebo Comparator: Pegylated interferon/placebo
Placebo tablets were supplied in the same dosing regimen as ribavirin, using the same number of tablets that would be given if ribavirin were being administered (eg, 3 placebo tablets twice daily for a 40-kg child who would receive 3 100-mg RV tablets twice daily).
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Drug: Pegylated Interferon/ribavirin |
Primary Outcome Measures
:
- Sustained Viral Response (SVR) [ Time Frame: at least 24 weeks after stopping treatment. ]SVR is defined as nondetectable hepatitis C virus ribonucleic acid (HCV RNA) in plasma
Secondary Outcome Measures
:
- Vital Signs Events. [ Time Frame: Every study visit ]Heart rate, blood pressure, respirations
- Laboratory Assessments [ Time Frame: Every study visit ]complete blood count,blood urea nitrogen,creatinine, glucose,calcium, phosphorus, aspartate aminotransferase,alanine aminotransferase, alkaline phosphatase, bilirubin
- Adverse Events [ Time Frame: Every study visit ]Influenza-like, headache, and gastrointestinal symptoms
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| Ages Eligible for Study: | 5 Years to 18 Years (Child, Adult) |
| Sexes Eligible for Study: | All |
| Accepts Healthy Volunteers: | No |
Criteria
Inclusion Criteria:
- Male or female patients who are 5-18 years of age at enrollment (not yet reached 18th birthday at screening).
- HCV viremia (by any test) present on 2 tests separated by at least 6 months.
- Chronic liver disease, as indicated by inflammation and/or fibrosis, consistent with chronic hepatitis C infection on a liver biopsy obtained within the past 24 months, as assessed by a qualified pathologist, not consistent with other known liver disease and not normal.
- Compensated liver disease (Child-Pugh Grade A clinical classification)
- Signed informed consent from parent/legal guardian and willingness of parent/legal guardian to abide by the requirements of the study.
- Hemoglobin values >11 g/dL for females; > 12 g/dL for males
- Normal thyroid stimulating hormone (TSH)
- Able to swallow a RV/placebo tablet
Exclusion Criteria:
- Any prior treatment with Interferon or RV
- Receipt of any investigational drug <6 weeks prior to the first dose of study drug
- Any systemic antiviral therapy <6 weeks prior to the first dose of study drug. Exception: patients who have taken or are expected to require acyclovir for herpetic lesions
- Positive test at screening for anti-HAV IgM Ab, HBsAg, anti-HBc IgM Ab, or anti-HIV Ab
- History or other evidence of a medical condition associated with chronic liver disease other than HCV (abnormal ceruloplasmin, alpha-1-antitrypsin, ANA>1:160, SMA>1:80, anti-LKM antibody > 60 units))
- History or other evidence of bleeding from esophageal varices
- Decompensated liver disease (e.g. conjugated bilirubin >1.5mg/dl, ascites, varices, Child-Pugh Grade B or C clinical classification)
- History of autoimmune or immunologically mediated disease (e.g. inflammatory bowel disease, idiopathic thrombocytopenic purpura, lupus erythematosus, autoimmune hemolytic anemia, scleroderma, severe psoriasis, clinical evidence of rheumatoid arthritis)
- Absolute neutrophil count <1500 cells/mm3 , hemoglobin <11 g/dL for females and <12 g/dL for males, white blood count>17.5 x 109/L, or platelet count <90,000/ mm3
- Serum creatinine level >1.5 times the upper limit of normal for age
- Major depression according to the American Psychiatric Association, or a history of severe psychiatric disorder, such as major psychoses, suicidal ideation and/or suicide attempt
- History or other evidence of chronic pulmonary or cardiac disease associated with functional limitation
- History of thyroid disease poorly controlled on prescribed medications. Patients with elevated thyroid stimulating hormone (TSH) concentrations with elevation of antibodies to thyroid peroxidase and any clinical manifestations of thyroid disease are excluded
- Poorly controlled diabetes as defined by glycosylated hemoglobin of > 8%
- History of solid organ or bone marrow transplantation
- Evidence of severe retinopathy
- Coagulopathy (international normalized ratio>1.5)
- Evidence of an active or suspected cancer or a history of malignancy where the risk of recurrence is >20% within 2 years.
- Hemoglobinopathy
- Hemophilia
- Severe retinopathy
- History of other evidence of severe illness or any other conditions which would make the patient, in the opinion of the investigator, unsuitable for the study
- Sexually active females of child-bearing potential (defined as age 10 years and older) and sexually active men who are not practicing two forms of effective contraception during treatment and during the 6 months after treatment has been concluded
- Females who have a positive serum pregnancy test within 7 days of initiation of treatment or who are breast-feeding
- Males whose female partners are pregnant
- Active substance abuse
- A sibling and/or any other child living in the same household or sharing the same primary caregiver enrolled in the study.
Information from the National Library of Medicine
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00100659
Locations
| United States, California | |
| University of California, San Francisco | |
| San Francisco, California, United States, 94143-0136 | |
| United States, Colorado | |
| The Children's Hospital | |
| Denver, Colorado, United States, 80218 | |
| United States, District of Columbia | |
| Children's National Medical Center | |
| Washington, District of Columbia, United States, 20010 | |
| United States, Florida | |
| University of Florida | |
| Gainesville, Florida, United States, 32610 | |
| United States, Indiana | |
| Indiana University School of Medicine, James Whitcomb Riley Hospital for Children | |
| Indianapolis, Indiana, United States, 46202-5225 | |
| United States, Maryland | |
| Johns Hopkins University | |
| Baltimore, Maryland, United States, 21287 | |
| United States, Massachusetts | |
| Children's Hospital Boston | |
| Boston, Massachusetts, United States, 02115 | |
| United States, New York | |
| Columbia University Medical Center | |
| New York, New York, United States, 10032 | |
| United States, Ohio | |
| Children's Hospital Medical Center | |
| Cincinnati, Ohio, United States, 45229-3039 | |
| United States, Pennsylvania | |
| Children's Hospital of Philadelphia | |
| Philadelphia, Pennsylvania, United States, 19104 | |
| United States, Washington | |
| Children's Hospital and Regional Medical Center | |
| Seattle, Washington, United States, 98105 | |
Sponsors and Collaborators
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Roche Pharma AG
Investigators
| Principal Investigator: | Kathleen B Schwarz, MD | Johns Hopkins University |
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
| Responsible Party: | National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK) |
| ClinicalTrials.gov Identifier: | NCT00100659 History of Changes |
| Other Study ID Numbers: |
67767 (completed) |
| First Posted: | January 5, 2005 Key Record Dates |
| Results First Posted: | July 1, 2013 |
| Last Update Posted: | July 19, 2013 |
| Last Verified: | July 2013 |
Keywords provided by National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK):
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pediatric hepatitis children HCV PEG PEG-2a peginterferon alfa-2a Pegylated Interferon RV |
ribavirin Pegasys CHC chronic hepatitis C chronic hepatitis C virus hepatitis c pediatric hepatitis pediatric HCV |
Additional relevant MeSH terms:
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Hepatitis Hepatitis A Hepatitis C Hepatitis, Chronic Hepatitis C, Chronic Liver Diseases Digestive System Diseases Hepatitis, Viral, Human Virus Diseases Enterovirus Infections |
Picornaviridae Infections RNA Virus Infections Flaviviridae Infections Interferons Ribavirin Antineoplastic Agents Antiviral Agents Anti-Infective Agents Antimetabolites Molecular Mechanisms of Pharmacological Action |