Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu
Trial record 39 of 396 for:    IFNA2 AND RBV AND sustained

Pegylated Interferon (PEG-IFN) Alfa-2b and Low Dose Ribavirin for the Treatment of Chronic Hepatitis C Patients With Genotype 1 High Viral Load and Low Body Weight (Study P05172)(COMPLETED)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT00686777
Recruitment Status : Completed
First Posted : May 30, 2008
Results First Posted : January 18, 2012
Last Update Posted : April 7, 2017
Sponsor:
Information provided by (Responsible Party):
Merck Sharp & Dohme Corp.

Tracking Information
First Submitted Date  ICMJE May 27, 2008
First Posted Date  ICMJE May 30, 2008
Results First Submitted Date  ICMJE December 12, 2011
Results First Posted Date  ICMJE January 18, 2012
Last Update Posted Date April 7, 2017
Study Start Date  ICMJE January 2008
Actual Primary Completion Date December 2010   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: December 12, 2011)
  • Percentage of Participants With Sustained Virologic Response (SVR) at 24 Weeks After the End of Treatment (EOT) or Discontinuation [ Time Frame: Measured at 24 weeks after the end of treatment (at the end of follow-up) ]
    SVR was defined as a viral response which was sustained at 24 weeks after the end of treatment as measured by Hepatitis C Virus Ribonucleic Acid (HCV-RNA) negativity. HCV-RNA negativity was assessed by an reverse transcriptase polymerase chain reaction (RT-PCR) method, where a negative response was defined by a negative qualitative HCV-RNA result.
  • Number of Participants Discontinuing Treatment [ Time Frame: From time of first treatment to Week 48 ]
    Prespecified adverse event discontinuance criteria included neutrophil count <500 /mm3, platelet count <50,000/mm3, and hemoglobin <8.5 g/dL.
Original Primary Outcome Measures  ICMJE
 (submitted: May 29, 2008)
  • Sustained virologic response (sustained HCV-RNA negativity) [ Time Frame: Measured at 24 weeks after the end of treatment (at the end of follow-up) ]
  • Treatment discontinuation [ Time Frame: Measured during the 48-week treatment phase of the study. ]
Change History Complete list of historical versions of study NCT00686777 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: December 12, 2011)
Percentage of Participants With HCV-RNA Negativity at 24 Weeks of Treatment and at EOT [ Time Frame: Measured at 24 weeks of treatment and at EOT (Treatment week 48) ]
HCV-RNA negativity was assessed by an RT-PCR method, where a negative response was defined by a negative qualitative HCV-RNA result.
Original Secondary Outcome Measures  ICMJE Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Pegylated Interferon (PEG-IFN) Alfa-2b and Low Dose Ribavirin for the Treatment of Chronic Hepatitis C Patients With Genotype 1 High Viral Load and Low Body Weight (Study P05172)(COMPLETED)
Official Title  ICMJE Low Dose Treatment of Ribavirin in Combination With PEG-IFN Alfa-2b in CHC Patients With genotype1 High Viral Load and Low Body Weight
Brief Summary The objective is to evaluate the efficacy and safety of the combination therapy with subcutaneous (SC) Pegylated Interferon (PEG-IFN) alfa-2b 1.5 ug/kg/week plus low-dose ribavirin administered for 48 weeks in participants with chronic hepatitis C virus (HCV) who are infected with HCV genotype 1 high viral load, and weigh 50 kg or less.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 4
Study Design  ICMJE Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Hepatitis C, Chronic
Intervention  ICMJE
  • Biological: Pegylated Interferon alfa-2b
    Pegylated Interferon alfa-2b 1.5 ug/kg SC once weekly for 48 weeks
    Other Name: SCH 54031
  • Drug: Ribavirin
    Ribavirin 400 mg/day orally
    Other Name: SCH 18908
Study Arms  ICMJE Experimental: PEG-IFN + Ribavirin
Pegylated Interferon alfa-2b was administered to participants at 1.5 μg/kg subcutaneously once weekly for 48 weeks. Ribavirin was administered orally every day after morning and evening meals for 48 weeks at 400 mg/day.
Interventions:
  • Biological: Pegylated Interferon alfa-2b
  • Drug: Ribavirin
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: January 12, 2011)
75
Original Estimated Enrollment  ICMJE
 (submitted: May 29, 2008)
90
Actual Study Completion Date  ICMJE December 2010
Actual Primary Completion Date December 2010   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • Diagnosed with chronic hepatitis C.
  • Minimum 20 years of age
  • Willing to use adequate contraception during the course of the study.
  • Participants who can be hospitalized for at least 14 days since treatment initiation.
  • Positive for HCV genotype 1 (genotype 1a and 1b) with high viral load (HCV-RNA >=100 kIU/mL).
  • Participants weighing over 40 kg to 50 kg.
  • Hematology results of:

    • hemoglobin levels >=12 g/dL
    • neutrophils >=1,500/mm^3
    • platelets >=100,000/mm^3

Exclusion Criteria:

  • Previous ribavirin therapy.
  • Previous interferon therapy within 90 days of registration.
  • Participants who received treatment with injectable products containing glycyrrhizin/cysteine/glycine (Stronger Neo-Minophagen C, etc.), Shosaikoto, or ursodeoxycholic acid within 30 days before the start of treatment
  • Participants who received treatment with an antiviral or anti-tumor drug or who received immunomodulating therapy (including steroids and radiotherapy) within 90 days before the start of treatment [excluding local administration and topical drugs].
  • Participants who received other investigational drugs within 180 days before the start of treatment.
  • Hepatitis Bs (HBs) antigen-positive
  • Antinuclear antibodies >=1:160
  • Fasting blood glucose >=110 mg/dL (however, participants with fasting blood glucose of 110 mg/dL to <126 mg/dL can be registered if HbA1c is <6.5%)
  • Participants diagnosed with liver cirrhosis in most recent celioscopy or liver biopsy.
  • Participants with or who have a history of any of the following: liver failure; hepatic encephalopathy, esophageal varices, or ascites; depression or schizophrenia requiring treatment or suicidal attempt or ideation; epileptic seizures requiring drug treatment; autoimmune disease (such as Hashimoto's disease, Crohn's disease, ulcerative colitis, chronic rheumatoid arthritis, idiopathic thrombocytopenic purpura, systemic erythematosus, autoimmune hemolytic anemia, and scleroderma); hepatic cancer
  • Participants with any of the following: liver disease such as autoimmune hepatitis, alcoholic liver disease, and drug-induced hepatic impairment; hemophilia; arrhythmia requiring treatment and participants with or who have a history of angina pectoris, cardiac failure, myocardial infarction, or life-threatening arrhythmia; hypertension (systolic BP of 160 mmHg or more and diastolic BP of 100 mmHg or more) not possible to control with drug therapy; chronic pulmonary disease; hemoglobinopathy (thalassemia, sickle cell anemia); malignant tumor or who have a history of malignant tumor within the past 5 years; thyroid function disorder not controlled by drug therapy.
  • Participants with organ transplants (excluding cornea and hair transplants).
  • Participants with a history of hypersensitivity to interferon preparations, nucleoside analogs, or biological products such as vaccine.
  • Participants with a specific response to PEG-IFN alfa-2b in a prick test to be conducted just before the initiation of treatment.
  • Participants who are pregnant or nursing (in the case of male Participants : partner is pregnant)
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 20 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Not Provided
Removed Location Countries Japan
 
Administrative Information
NCT Number  ICMJE NCT00686777
Other Study ID Numbers  ICMJE P05172
JPC-06-320-40
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE
Plan to Share IPD: Yes
Plan Description:

http://www.merck.com/clinical-trials/pdf/Merck%20Procedure%20on%20Clinical%20Trial%20Data%20Access%20Final_Updated%20July_9_2014.pdf

http://engagezone.msd.com/ds_documentation.php

Responsible Party Merck Sharp & Dohme Corp.
Study Sponsor  ICMJE Merck Sharp & Dohme Corp.
Collaborators  ICMJE Not Provided
Investigators  ICMJE Not Provided
PRS Account Merck Sharp & Dohme Corp.
Verification Date March 2017

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP