PEDS-C: Pegylated Interferon +/- Ribavirin for Children With Hepatitis C
Pegylated Interferon +/- Ribavirin for Children With Hepatitis C
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.
調査の概要
研究の種類
入学 (実際)
段階
- フェーズ 3
連絡先と場所
研究場所
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California
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San Francisco、California、アメリカ、94143-0136
- University of California, San Francisco
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Colorado
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Denver、Colorado、アメリカ、80218
- The Children's Hospital
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District of Columbia
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Washington、District of Columbia、アメリカ、20010
- Children's National Medical Center
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Florida
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Gainesville、Florida、アメリカ、32610
- University of Florida
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Indiana
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Indianapolis、Indiana、アメリカ、46202-5225
- Indiana University School of Medicine, James Whitcomb Riley Hospital for Children
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Maryland
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Baltimore、Maryland、アメリカ、21287
- Johns Hopkins University
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Massachusetts
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Boston、Massachusetts、アメリカ、02115
- Children's Hospital Boston
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New York
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New York、New York、アメリカ、10032
- Columbia University Medical Center
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Ohio
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Cincinnati、Ohio、アメリカ、45229-3039
- Children's Hospital Medical Center
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Pennsylvania
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Philadelphia、Pennsylvania、アメリカ、19104
- Children's Hospital of Philadelphia
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Washington
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Seattle、Washington、アメリカ、98105
- Children's Hospital and Regional Medical Center
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参加基準
適格基準
就学可能な年齢
健康ボランティアの受け入れ
受講資格のある性別
説明
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.
研究計画
研究はどのように設計されていますか?
デザインの詳細
- 主な目的:処理
- 割り当て:ランダム化
- 介入モデル:並列代入
- マスキング:4倍
武器と介入
参加者グループ / アーム |
介入・治療 |
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アクティブコンパレータ: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. |
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プラセボコンパレーター: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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この研究は何を測定していますか?
主要な結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
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Sustained Viral Response (SVR)
時間枠:at least 24 weeks after stopping treatment.
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SVR is defined as nondetectable hepatitis C virus ribonucleic acid (HCV RNA) in plasma
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at least 24 weeks after stopping treatment.
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二次結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
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Adverse Events
時間枠:At any time up to 72 weeks
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Influenza-like, headache, and gastrointestinal symptoms
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At any time up to 72 weeks
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協力者と研究者
協力者
捜査官
- 主任研究者:Kathleen B Schwarz, MD、Johns Hopkins University
出版物と役立つリンク
一般刊行物
- Murray KF, Rodrigue JR, Gonzalez-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. doi: 10.1177/1740774507085445.
- 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, Gonzalez-Peralta RP. Peginterferon with or without ribavirin has minimal effect on quality of life, behavioral/emotional, and cognitive outcomes in children. Hepatology. 2011 May;53(5):1468-75. doi: 10.1002/hep.24248.
- 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 combination of ribavirin and peginterferon is superior to peginterferon and placebo for children and adolescents with chronic hepatitis C. Gastroenterology. 2011 Feb;140(2):450-458.e1. doi: 10.1053/j.gastro.2010.10.047. Epub 2010 Oct 28.
- 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 Peds-C Trial. Hepatology. 2008 Mar;47(3):836-43. doi: 10.1002/hep.22094.
- 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/MPG.0b013e3181b99cf0.
- 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 Nutr. 2015 Feb;60(2):165-70. doi: 10.1097/MPG.0000000000000604.
- 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 Chronic Hepatitis C. J Pediatr Gastroenterol Nutr. 2016 Jan;62(1):93-6. doi: 10.1097/MPG.0000000000000929. Erratum In: J Pediatr Gastroenterol Nutr. 2016 Feb;62(2):357. J Pediatr Gastroenterol Nutr. 2016 Jan 11;:
- Molleston JP, Mellman W, Narkewicz MR, Balistreri WF, Gonzalez-Peralta RP, Jonas MM, Lobritto SJ, Mohan P, Murray KF, Njoku D, Rosenthal P, Barton BA, Talor MV, Cheng I, Schwarz KB, Haber BA; PEDS-C Clinical Research Network. Autoantibodies and autoimmune disease during treatment of children with chronic hepatitis C. J Pediatr Gastroenterol Nutr. 2013 Mar;56(3):304-10. doi: 10.1097/MPG.0b013e3182774cae.
- Jonas MM, Balistreri W, Gonzalez-Peralta RP, Haber B, Lobritto S, Mohan P, Molleston JP, Murray KF, Narkewicz MR, Rosenthal P, Schwarz KB, Barton BA, Shepherd JA, Mitchell PD, Duggan C. Pegylated interferon for chronic hepatitis C in children affects growth and body composition: results from the pediatric study of hepatitis C (PEDS-C) trial. Hepatology. 2012 Aug;56(2):523-31. doi: 10.1002/hep.25690. Epub 2012 Jul 6.
研究記録日
主要日程の研究
研究開始
一次修了 (実際)
研究の完了 (実際)
試験登録日
最初に提出
QC基準を満たした最初の提出物
最初の投稿 (見積もり)
学習記録の更新
投稿された最後の更新 (実際)
QC基準を満たした最後の更新が送信されました
最終確認日
詳しくは
本研究に関する用語
キーワード
追加の関連 MeSH 用語
その他の研究ID番号
- 67767 (completed)
- U01DK067767 (米国 NIH グラント/契約)
個々の参加者データ (IPD) の計画
個々の参加者データ (IPD) を共有する予定はありますか?
IPD プランの説明
IPD 共有時間枠
IPD 共有アクセス基準
IPD 共有サポート情報タイプ
- STUDY_PROTOCOL
- SAP
- ANALYTIC_CODE
- CSR
この情報は、Web サイト clinicaltrials.gov から変更なしで直接取得したものです。研究の詳細を変更、削除、または更新するリクエストがある場合は、register@clinicaltrials.gov。 までご連絡ください。 clinicaltrials.gov に変更が加えられるとすぐに、ウェブサイトでも自動的に更新されます。
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