PEDS-C: Pegylated Interferon +/- Ribavirin for Children With Hepatitis C

Chronic Hepatitis C Clinical Trial

Official title:

Pegylated Interferon +/- Ribavirin for Children With Hepatitis C

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00100659
• Other study ID #: 67767 (completed)
• Secondary ID: U01DK067767
• Status: Completed
• Phase: Phase 3
• Start date: December 2004
• Est. completion date: February 2010

Study information

• Verified date: August 2018
• Source: National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 114
• Est. completion date: February 2010
• Est. primary completion date: August 2008
• Accepts healthy volunteers: No
• Gender: All
• Age group: 5 Years to 18 Years

Eligibility

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 ribavirin/placebo tablet

Exclusion Criteria:

• Any prior treatment with Interferon or ribavirin (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.

Related Conditions & MeSH terms

• Chronic Hepatitis C
• Hepatitis
• Hepatitis A
• Hepatitis C
• Hepatitis C, Chronic
• Hepatitis, Chronic

Intervention

Drug:
• Pegylated Interferon/ribavirin

Locations

Country	Name	City	State
United States	Johns Hopkins University	Baltimore	Maryland
United States	Children's Hospital Boston	Boston	Massachusetts
United States	Children's Hospital Medical Center	Cincinnati	Ohio
United States	The Children's Hospital	Denver	Colorado
United States	University of Florida	Gainesville	Florida
United States	Indiana University School of Medicine, James Whitcomb Riley Hospital for Children	Indianapolis	Indiana
United States	Columbia University Medical Center	New York	New York
United States	Children's Hospital of Philadelphia	Philadelphia	Pennsylvania
United States	University of California, San Francisco	San Francisco	California
United States	Children's Hospital and Regional Medical Center	Seattle	Washington
United States	Children's National Medical Center	Washington	District of Columbia

Sponsors (2)

Lead Sponsor	Collaborator
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)	Roche Pharma AG

Country where clinical trial is conducted

United States, 

References & Publications (7)

Delgado-Borrego A, Gonzalez-Peralta RP, Raza R, Negre B, Goodman ZD, Jonas MM, Chung RT, Ludwig DA; PEDS-C Clinical Research Network. Correlates of adiponectin in hepatitis C-infected children: the importance of body mass index. J Pediatr Gastroenterol Nu — View Citation

Goodman ZD, Makhlouf HR, Liu L, Balistreri W, Gonzalez-Peralta RP, Haber B, Jonas MM, Mohan P, Molleston JP, Murray KF, Narkewicz MR, Rosenthal P, Smith LJ, Robuck PR, Schwarz KB. Pathology of chronic hepatitis C in children: liver biopsy findings in the — View Citation

Murray KF, Rodrigue JR, González-Peralta RP, Shepherd J, Barton BA, Robuck PR, Schwarz KB; PEDS-C Clinical Research Network. Design of the PEDS-C trial: pegylated interferon +/- ribavirin for children with chronic hepatitis C viral infection. Clin Trials. 2007;4(6):661-73. — View Citation

Narkewicz MR, Rosenthal P, Schwarz KB, Drack A, Margolis T, Repka MX; PEDS-C Study Group. Ophthalmologic complications in children with chronic hepatitis C treated with pegylated interferon. J Pediatr Gastroenterol Nutr. 2010 Aug;51(2):183-6. doi: 10.1097 — View Citation

Rodrigue JR, Balistreri W, Haber B, Jonas MM, Mohan P, Molleston JP, Murray KF, Narkewicz MR, Rosenthal P, Smith LJ, Lobritto SJ, Schwarz KB, Robuck PR, Barton B, González-Peralta RP. Peginterferon with or without ribavirin has minimal effect on quality o — View Citation

Schwarz KB, Gonzalez-Peralta RP, Murray KF, Molleston JP, Haber BA, Jonas MM, Rosenthal P, Mohan P, Balistreri WF, Narkewicz MR, Smith L, Lobritto SJ, Rossi S, Valsamakis A, Goodman Z, Robuck PR, Barton BA; Peds-C Clinical Research Network. The combinatio — View Citation

Schwarz KB, Molleston JP, Jonas MM, Wen J, Murray KF, Rosenthal P, Gonzalez-Peralta RP, Lobritto SJ, Mogul D, Pavlovic V, Warne C, Wat C, Thompson B. Durability of Response in Children Treated With Pegylated Interferon alfa [corrected] 2a ± Ribavirin for — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Sustained Viral Response (SVR)	SVR is defined as nondetectable hepatitis C virus ribonucleic acid (HCV RNA) in plasma	at least 24 weeks after stopping treatment.
Secondary	Adverse Events	Influenza-like, headache, and gastrointestinal symptoms	At any time up to 72 weeks