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Trial record 64 of 1270 for:    IFNA2

Efficacy and Safety of Short Course Therapy With Peginterferon Alpha-2b (PEG-IFN Alfa-2b) and Ribavirin (RBV) for Chronic Hepatitis C (Genotype 4) Participants Achieving a Rapid Virological Response at Week 4 of Treatment (MK-8908B-059) (START 4)

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ClinicalTrials.gov Identifier: NCT01606800
Recruitment Status : Terminated (The trial was terminated due to change in new standard of therapy during the study period.)
First Posted : May 28, 2012
Results First Posted : February 23, 2016
Last Update Posted : October 25, 2018
Sponsor:
Information provided by (Responsible Party):
Merck Sharp & Dohme Corp.

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Condition Hepatitis C, Chronic
Interventions Drug: PEG-IFN alfa-2b
Drug: ribavirin
Enrollment 45
Recruitment Details  
Pre-assignment Details  
Arm/Group Title 44 Weeks of PEG-IFN Alfa-2b + RBV 20 Weeks of PEG-IFN Alfa-2b + RBV
Hide Arm/Group Description Participants achieving rapid virologic response (RVR) after 4 weeks of pegylated interferon (PEG-INF) alfa-2b + ribavirin (RBV) treatment continued to receive PEG-INF alpha-2b + RBV for an additional 44 weeks. Participants achieving RVR after 4 weeks of PEG-INF alfa-2b + RBV treatment continued to receive PEG-INF alpha-2b + RBV for an additional 20 weeks.
Period Title: Overall Study
Started 22 23
Treated 22 23
Completed 17 21
Not Completed 5 2
Reason Not Completed
Adverse Event             3             1
Participant withdrew consent             0             1
Missing completion status             2             0
Arm/Group Title 44 Weeks of PEG-IFN Alfa-2b + RBV 20 Weeks of PEG-IFN Alfa-2b + RBV Total
Hide Arm/Group Description Participants achieving rapid virologic response (RVR) after 4 weeks of pegylated interferon (PEG-INF) alfa-2b + ribavirin (RBV) treatment continued to receive PEG-INF alpha-2b + RBV for an additional 44 weeks. Participants achieving RVR after 4 weeks of PEG-INF alfa-2b + RBV treatment continued to receive PEG-INF alpha-2b + RBV for an additional 20 weeks. Total of all reporting groups
Overall Number of Baseline Participants 22 23 45
Hide Baseline Analysis Population Description
All Treated Population, which included all participants who received at least one dose of study medication after RVR.
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 22 participants 23 participants 45 participants
38.4  (10.79) 37.1  (11.22) 37.7  (10.91)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 22 participants 23 participants 45 participants
Female
9
  40.9%
10
  43.5%
19
  42.2%
Male
13
  59.1%
13
  56.5%
26
  57.8%
1.Primary Outcome
Title Number of Participants Achieving Sustained Virologic Response (SVR)
Hide Description SVR was defined as undetectable HCV RNA levels 24 weeks after the completion of therapy.
Time Frame At 24 weeks after the completion of therapy (up to 72 weeks)
Hide Outcome Measure Data
Hide Analysis Population Description
All Treated Population, which included all participants who received at least one dose of study medication after RVR.
Arm/Group Title 44 Weeks of PEG-IFN Alfa-2b + RBV 20 Weeks of PEG-IFN Alfa-2b + RBV
Hide Arm/Group Description:
Participants achieving rapid virologic response (RVR) after 4 weeks of pegylated interferon (PEG-INF) alfa-2b + ribavirin (RBV) treatment continued to receive PEG-INF alpha-2b + RBV for an additional 44 weeks.
Participants achieving RVR after 4 weeks of PEG-INF alfa-2b + RBV treatment continued to receive PEG-INF alpha-2b + RBV for an additional 20 weeks.
Overall Number of Participants Analyzed 22 23
Measure Type: Number
Unit of Measure: Participants
13 22
Time Frame Up to 72 weeks
Adverse Event Reporting Description All Treated Population, which included all participants who received at least one dose of study medication after RVR.
 
Arm/Group Title 44 Weeks of PEG-IFN Alfa-2b + RBV 20 Weeks of PEG-IFN Alfa-2b + RBV
Hide Arm/Group Description Participants achieving rapid virologic response (RVR) after 4 weeks of pegylated interferon (PEG-INF) alfa-2b + ribavirin (RBV) treatment continued to receive PEG-INF alpha-2b + RBV for an additional 44 weeks. Participants achieving RVR after 4 weeks of PEG-INF alfa-2b + RBV treatment continued to receive PEG-INF alpha-2b + RBV for an additional 20 weeks.
All-Cause Mortality
44 Weeks of PEG-IFN Alfa-2b + RBV 20 Weeks of PEG-IFN Alfa-2b + RBV
Affected / at Risk (%) Affected / at Risk (%)
Total   --/--   --/-- 
Show Serious Adverse Events Hide Serious Adverse Events
44 Weeks of PEG-IFN Alfa-2b + RBV 20 Weeks of PEG-IFN Alfa-2b + RBV
Affected / at Risk (%) Affected / at Risk (%)
Total   0/22 (0.00%)   2/23 (8.70%) 
Blood and lymphatic system disorders     
Anemia  1  0/22 (0.00%)  1/23 (4.35%) 
Leukopaenia  1  0/22 (0.00%)  1/23 (4.35%) 
Indicates events were collected by systematic assessment
1
Term from vocabulary, 15.1
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
44 Weeks of PEG-IFN Alfa-2b + RBV 20 Weeks of PEG-IFN Alfa-2b + RBV
Affected / at Risk (%) Affected / at Risk (%)
Total   16/22 (72.73%)   13/23 (56.52%) 
Blood and lymphatic system disorders     
Anemia  1  5/22 (22.73%)  2/23 (8.70%) 
Eye disorders     
Vision blurred  1  2/22 (9.09%)  1/23 (4.35%) 
Gastrointestinal disorders     
Abdominal pain upper  1  2/22 (9.09%)  1/23 (4.35%) 
General disorders     
Fatigue  1  5/22 (22.73%)  1/23 (4.35%) 
Pyrexia  1  2/22 (9.09%)  0/23 (0.00%) 
Investigations     
Blood thyroid stimulating hormone increased  1  2/22 (9.09%)  2/23 (8.70%) 
Musculoskeletal and connective tissue disorders     
Bone pain  1  2/22 (9.09%)  1/23 (4.35%) 
Arthralgia  1  2/22 (9.09%)  0/23 (0.00%) 
Nervous system disorders     
Headache  1  3/22 (13.64%)  1/23 (4.35%) 
Respiratory, thoracic and mediastinal disorders     
Cough  1  2/22 (9.09%)  2/23 (8.70%) 
Dyspnoea  1  2/22 (9.09%)  0/23 (0.00%) 
Skin and subcutaneous tissue disorders     
Pruritus  1  3/22 (13.64%)  2/23 (8.70%) 
Alopecia  1  0/22 (0.00%)  2/23 (8.70%) 
Indicates events were collected by systematic assessment
1
Term from vocabulary, 15.1
This Trial was prematurely terminated due to the availability of more promising treatment for HCV participants and the change in treatment guidelines, which will offer the patient a better treatment opportunity.
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.
The investigator agrees to provide to the sponsor 45 days prior to submission for publication or presentation, review copies of abstracts or manuscripts for publication (including, without limitation, slides and texts of oral or other public presentations and texts of any transmission through any electronic media, eg, any computer access system such as the Internet, World Wide Web, etc) that report any results of the trial.
Results Point of Contact
Name/Title: Senior Vice President, Global Clinical Development
Organization: Merck Sharp & Dohme Corp.
Phone: 1-800-672-6372
Responsible Party: Merck Sharp & Dohme Corp.
ClinicalTrials.gov Identifier: NCT01606800     History of Changes
Other Study ID Numbers: 8908B-059
MK-8908B-059 ( Other Identifier: Merck Registration Number )
First Submitted: May 24, 2012
First Posted: May 28, 2012
Results First Submitted: January 26, 2016
Results First Posted: February 23, 2016
Last Update Posted: October 25, 2018