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

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ClinicalTrials.gov Identifier: NCT00100659
Recruitment Status : Completed
First Posted : January 5, 2005
Results First Posted : July 1, 2013
Last Update Posted : October 24, 2018
Sponsor:
Collaborator:
Roche Pharma AG
Information provided by (Responsible Party):
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor);   Primary Purpose: Treatment
Condition Chronic Hepatitis C
Intervention Drug: Pegylated Interferon/ribavirin
Enrollment 114
Recruitment Details December 2004 to May 2006 at 11 US medical centers
Pre-assignment Details Failure to meet inclusion criteria
Arm/Group Title Pegylated Interferon/Ribavirin Pegylated Interferon/Placebo
Hide Arm/Group Description

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.

Placebo tablets were supplied in the same dosing regimen as ribavirin (RV), 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).
Period Title: Overall Study
Started 55 59
Completed 52 57
Not Completed 3 2
Arm/Group Title Pegylated Interferon/Ribavirin Pegylated Interferon/Placebo Total
Hide Arm/Group Description

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.

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). Total of all reporting groups
Overall Number of Baseline Participants 55 59 114
Hide Baseline Analysis Population Description
[Not Specified]
Age, Categorical  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 55 participants 59 participants 114 participants
<=18 years
55
 100.0%
59
 100.0%
114
 100.0%
Between 18 and 65 years
0
   0.0%
0
   0.0%
0
   0.0%
>=65 years
0
   0.0%
0
   0.0%
0
   0.0%
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 55 participants 59 participants 114 participants
10.7  (3.3) 10.8  (3.6) 10.75  (3.4)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 55 participants 59 participants 114 participants
Female
28
  50.9%
23
  39.0%
51
  44.7%
Male
27
  49.1%
36
  61.0%
63
  55.3%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
United States Number Analyzed 55 participants 59 participants 114 participants
55 59 114
1.Primary Outcome
Title Sustained Viral Response (SVR)
Hide Description SVR is defined as nondetectable hepatitis C virus ribonucleic acid (HCV RNA) in plasma
Time Frame at least 24 weeks after stopping treatment.
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title PEG/RV PEG/Placebo
Hide Arm/Group Description:
Pegylated interferon/ribavirin
Pegylated interferon/placebo
Overall Number of Participants Analyzed 55 57
Measure Type: Number
Unit of Measure: participants
29 12
2.Secondary Outcome
Title Adverse Events
Hide Description Influenza-like, headache, and gastrointestinal symptoms
Time Frame At any time up to 72 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Pegylated Interferon/Ribavirin Pegylated Interferon/Placebo
Hide Arm/Group Description:

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.

Pegylated Interferon/ribavirin

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).

Pegylated Interferon/ribavirin

Overall Number of Participants Analyzed 55 57
Measure Type: Count of Participants
Unit of Measure: Participants
Influenza-like symptoms
50
  90.9%
50
  87.7%
Headache
34
  61.8%
30
  52.6%
Gastrointestinal symptoms
31
  56.4%
37
  64.9%
Time Frame [Not Specified]
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Pegylated Interferon/Ribavirin Pegylated Interferon/Placebo
Hide Arm/Group Description

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.

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).
All-Cause Mortality
Pegylated Interferon/Ribavirin Pegylated Interferon/Placebo
Affected / at Risk (%) Affected / at Risk (%)
Total   --/--      --/--    
Show Serious Adverse Events Hide Serious Adverse Events
Pegylated Interferon/Ribavirin Pegylated Interferon/Placebo
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   2/55 (3.64%)      1/59 (1.69%)    
Endocrine disorders     
New onset diabetes mellitus Type 1  [1]  1/55 (1.82%)  1 0/59 (0.00%)  0
Hepatobiliary disorders     
Complications of a liver biopsy  [2]  0/55 (0.00%)  0 1/59 (1.69%)  1
Psychiatric disorders     
Suicide gesture  [1]  1/55 (1.82%)  1 0/59 (0.00%)  0
Indicates events were collected by systematic assessment
[1]
Hospitalization
[2]
Hospitalization and cholecystectomy
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 1%
Pegylated Interferon/Ribavirin Pegylated Interferon/Placebo
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   51/55 (92.73%)      52/59 (88.14%)    
Gastrointestinal disorders     
Gastrointestinal symptoms   31/55 (56.36%)  37/59 (62.71%) 
General disorders     
Flu-like symptoms   50/55 (90.91%)  50/59 (84.75%) 
Headache   34/55 (61.82%)  30/59 (50.85%) 
Injection site reaction   25/55 (45.45%)  27/59 (45.76%) 
Irritability   17/55 (30.91%)  13/59 (22.03%) 
Fatigue   15/55 (27.27%)  15/59 (25.42%) 
Anorexia   7/55 (12.73%)  11/59 (18.64%) 
Trouble sleeping   6/55 (10.91%)  11/59 (18.64%) 
Musculoskeletal and connective tissue disorders     
Joint and muscle aches   20/55 (36.36%)  20/59 (33.90%) 
Psychiatric disorders     
Depression   2/55 (3.64%)  7/59 (11.86%) 
Skin and subcutaneous tissue disorders     
Rash   11/55 (20.00%)  14/59 (23.73%) 
Itching   8/55 (14.55%)  9/59 (15.25%) 
Indicates events were collected by systematic assessment
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
Results Point of Contact
Name/Title: Kathleen B. Schwarz, M.D.
Organization: Johns Hopkins University School of Medicine
Phone: 410-955-8769
Publications of Results:
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)
U01DK067767 ( U.S. NIH Grant/Contract )
First Submitted: January 4, 2005
First Posted: January 5, 2005
Results First Submitted: May 10, 2013
Results First Posted: July 1, 2013
Last Update Posted: October 24, 2018