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Trial record 22 of 538 for:    IFNA2 AND RBV AND Hepatitis

Effects of Pegylated Interferon Alfa-2b and Ribavirin After Orthotopic Liver Transplantation in Subjects With Chronic Hepatitis C Recurrence (P04590AM3)(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: NCT00378599
Recruitment Status : Completed
First Posted : September 20, 2006
Results First Posted : July 16, 2010
Last Update Posted : April 6, 2017
Sponsor:
Information provided by (Responsible Party):
Merck Sharp & Dohme Corp.

Study Type Interventional
Study Design Allocation: Non-Randomized;   Intervention Model: Single Group Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Conditions Liver Transplantation
Hepatitis C, Chronic
Liver Cirrhosis
Intervention Drug: Combination of (a) pegylated interferon alfa-2b and (b) rebetol
Enrollment 125
Recruitment Details  
Pre-assignment Details  
Arm/Group Title PEG-Intron Plus Ribavirin
Hide Arm/Group Description PEG-Intron plus ribavirin treatment for up to 48 weeks with 24-week follow up
Period Title: Overall Study
Started 125
Completed 73
Not Completed 52
Reason Not Completed
Adverse Event             38
Protocol Violation             2
Treatment failure             7
Withdrawal by Subject             5
Arm/Group Title PEG-Intron Plus Ribavirin
Hide Arm/Group Description PEG-Intron plus ribavirin treatment for up to 48 weeks with 24-week follow up
Overall Number of Baseline Participants 125
Hide Baseline Analysis Population Description
[Not Specified]
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 125 participants
54.2  (5.7)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 125 participants
Female
19
  15.2%
Male
106
  84.8%
1.Primary Outcome
Title A Sustained Virologic Response (SVR), Defined as a Plasma HCV RNA Level Below the Lower Level of Quantitation (LLQ) at 24 Weeks Post-treatment
Hide Description Number of participants with SVR at 24-week follow up after treatment with PEG-Intron and Ribavirin in post-orthotopic liver transplant recipients with recurrent HCV.
Time Frame 24 weeks after completion of up to 48 weeks of therapy
Hide Outcome Measure Data
Hide Analysis Population Description
Intent to Treat (ITT) Data Set: All enrolled subjects who received at least one dose of any study medication (PEG-Intron or Rebetol (RBV)). Analysis of all primary and secondary efficacy endpoints and safety variables was based on the ITT population.
Arm/Group Title PEG-Intron Plus Ribavirin
Hide Arm/Group Description:
PEG-Intron plus ribavirin treatment for up to 48 weeks with 24-week follow up
Overall Number of Participants Analyzed 125
Measure Type: Number
Unit of Measure: Participants
36
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection PEG-Intron Plus Ribavirin
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Method of Estimation Estimation Parameter Binomial Approximation
Estimated Value .288
Confidence Interval (2-Sided) 95%
0.21 to 0.38
Estimation Comments [Not Specified]
Time Frame [Not Specified]
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Pegylated Interferon Alfa-2b and Ribavirin
Hide Arm/Group Description [Not Specified]
All-Cause Mortality
Pegylated Interferon Alfa-2b and Ribavirin
Affected / at Risk (%)
Total   --/--    
Show Serious Adverse Events Hide Serious Adverse Events
Pegylated Interferon Alfa-2b and Ribavirin
Affected / at Risk (%) # Events
Total   32/125 (25.60%)    
Blood and lymphatic system disorders   
ANAEMIA  1  5/125 (4.00%)  5
LEUKOPENIA  1  2/125 (1.60%)  2
NEUTROPENIA  1  1/125 (0.80%)  1
PANCYTOPENIA  1  1/125 (0.80%)  1
THROMBOCYTOPENIA  1  2/125 (1.60%)  2
Cardiac disorders   
MYOCARDIAL INFARCTION  1  1/125 (0.80%)  1
Ear and labyrinth disorders   
VERTIGO  1  1/125 (0.80%)  1
Gastrointestinal disorders   
ABDOMINAL PAIN  1  1/125 (0.80%)  1
DIARRHOEA  1  2/125 (1.60%)  4
NAUSEA  1  2/125 (1.60%)  3
VOMITING  1  3/125 (2.40%)  4
General disorders   
ASTHENIA  1  1/125 (0.80%)  1
CHEST PAIN  1  3/125 (2.40%)  3
CHILLS  1  1/125 (0.80%)  1
MALAISE  1  2/125 (1.60%)  2
PYREXIA  1  2/125 (1.60%)  2
Hepatobiliary disorders   
AUTOIMMUNE HEPATITIS  1  1/125 (0.80%)  1
CHOLANGITIS  1  1/125 (0.80%)  1
HEPATIC FAILURE  1  1/125 (0.80%)  1
Immune system disorders   
LIVER TRANSPLANT REJECTION  1  2/125 (1.60%)  3
Infections and infestations   
APPENDICITIS  1  1/125 (0.80%)  1
CELLULITIS  1  3/125 (2.40%)  3
CLOSTRIDIUM DIFFICILE COLITIS  1  2/125 (1.60%)  2
GASTROENTERITIS  1  1/125 (0.80%)  1
GASTROENTERITIS VIRAL  1  1/125 (0.80%)  1
OSTEOMYELITIS  1  1/125 (0.80%)  1
PNEUMONIA  1  4/125 (3.20%)  4
SUBCUTANEOUS ABSCESS  1  1/125 (0.80%)  1
URINARY TRACT INFECTION  1  1/125 (0.80%)  1
Injury, poisoning and procedural complications   
ANASTOMOTIC COMPLICATION  1  1/125 (0.80%)  1
CONTUSION  1  1/125 (0.80%)  1
POST PROCEDURAL DISCHARGE  1  1/125 (0.80%)  1
Investigations   
HAEMOGLOBIN DECREASED  1  1/125 (0.80%)  1
Metabolism and nutrition disorders   
DEHYDRATION  1  3/125 (2.40%)  3
HYPERKALAEMIA  1  1/125 (0.80%)  1
HYPONATRAEMIA  1  1/125 (0.80%)  1
Nervous system disorders   
CONVULSION  1  1/125 (0.80%)  1
HEADACHE  1  3/125 (2.40%)  3
SYNCOPE  1  1/125 (0.80%)  1
Psychiatric disorders   
DRUG ABUSE  1  1/125 (0.80%)  1
MENTAL STATUS CHANGES  1  1/125 (0.80%)  1
SUICIDAL IDEATION  1  1/125 (0.80%)  1
Renal and urinary disorders   
RENAL FAILURE ACUTE  1  1/125 (0.80%)  1
Respiratory, thoracic and mediastinal disorders   
DYSPNOEA  1  1/125 (0.80%)  1
OROPHARYNGEAL PAIN  1  1/125 (0.80%)  1
PRODUCTIVE COUGH  1  1/125 (0.80%)  1
Social circumstances   
TREATMENT NONCOMPLIANCE  1  1/125 (0.80%)  1
Surgical and medical procedures   
LEG AMPUTATION  1  1/125 (0.80%)  1
SPLENECTOMY  1  1/125 (0.80%)  1
Indicates events were collected by systematic assessment
1
Term from vocabulary, MedDRA 12.0
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
Pegylated Interferon Alfa-2b and Ribavirin
Affected / at Risk (%) # Events
Total   125/125 (100.00%)    
Blood and lymphatic system disorders   
ANAEMIA  1  91/125 (72.80%)  162
LEUKOPENIA  1  17/125 (13.60%)  25
NEUTROPENIA  1  39/125 (31.20%)  51
THROMBOCYTOPENIA  1  16/125 (12.80%)  20
Eye disorders   
VISION BLURRED  1  11/125 (8.80%)  11
Gastrointestinal disorders   
ABDOMINAL DISCOMFORT  1  12/125 (9.60%)  13
ABDOMINAL PAIN  1  13/125 (10.40%)  19
CONSTIPATION  1  8/125 (6.40%)  9
DIARRHOEA  1  51/125 (40.80%)  73
DRY MOUTH  1  11/125 (8.80%)  11
NAUSEA  1  59/125 (47.20%)  72
STOMATITIS  1  15/125 (12.00%)  15
VOMITING  1  32/125 (25.60%)  44
General disorders   
ASTHENIA  1  10/125 (8.00%)  13
CHILLS  1  28/125 (22.40%)  28
FATIGUE  1  89/125 (71.20%)  112
INFLUENZA LIKE ILLNESS  1  18/125 (14.40%)  22
INJECTION SITE ERYTHEMA  1  16/125 (12.80%)  17
INJECTION SITE RASH  1  7/125 (5.60%)  7
IRRITABILITY  1  27/125 (21.60%)  27
MALAISE  1  7/125 (5.60%)  11
OEDEMA PERIPHERAL  1  9/125 (7.20%)  10
PAIN  1  18/125 (14.40%)  20
PYREXIA  1  35/125 (28.00%)  49
Infections and infestations   
INFLUENZA  1  8/125 (6.40%)  8
SINUSITIS  1  7/125 (5.60%)  9
UPPER RESPIRATORY TRACT INFECTION  1  7/125 (5.60%)  8
Investigations   
BLOOD CREATININE INCREASED  1  10/125 (8.00%)  13
WEIGHT DECREASED  1  29/125 (23.20%)  30
Metabolism and nutrition disorders   
ANOREXIA  1  15/125 (12.00%)  16
DECREASED APPETITE  1  33/125 (26.40%)  38
HYPERKALAEMIA  1  8/125 (6.40%)  9
Musculoskeletal and connective tissue disorders   
ARTHRALGIA  1  26/125 (20.80%)  29
BACK PAIN  1  20/125 (16.00%)  22
MUSCLE SPASMS  1  11/125 (8.80%)  13
MYALGIA  1  21/125 (16.80%)  22
PAIN IN EXTREMITY  1  11/125 (8.80%)  11
Nervous system disorders   
DIZZINESS  1  31/125 (24.80%)  36
HEADACHE  1  79/125 (63.20%)  98
HYPOAESTHESIA  1  8/125 (6.40%)  10
TREMOR  1  7/125 (5.60%)  7
Psychiatric disorders   
ANXIETY  1  19/125 (15.20%)  21
DEPRESSION  1  29/125 (23.20%)  36
INSOMNIA  1  39/125 (31.20%)  41
Respiratory, thoracic and mediastinal disorders   
COUGH  1  18/125 (14.40%)  23
DYSPNOEA  1  32/125 (25.60%)  37
DYSPNOEA EXERTIONAL  1  15/125 (12.00%)  17
OROPHARYNGEAL PAIN  1  12/125 (9.60%)  14
RESPIRATORY TRACT CONGESTION  1  7/125 (5.60%)  7
Skin and subcutaneous tissue disorders   
ALOPECIA  1  13/125 (10.40%)  13
DRY SKIN  1  12/125 (9.60%)  12
PRURITUS  1  18/125 (14.40%)  19
RASH  1  32/125 (25.60%)  41
Vascular disorders   
HYPERTENSION  1  8/125 (6.40%)  8
Indicates events were collected by systematic assessment
1
Term from vocabulary, MedDRA 12.0
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.
Lead investigator agrees not to publish or publicly present any interim results of the Study without prior written consent of the sponsor. Lead investigator further agrees to provide 45 days written notice to the sponsor prior to submission for publication or presentation to permit the sponsor to review copies of abstracts or manuscripts for publication, which report any results of the Study. Sponsor shall have the right to review and comment on any presentation, including editorial rights.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: Senior Vice President, Global Clinical Development
Organization: Merck Sharp & Dohme Corp.
EMail: ClinicalTrialsDisclosure@merck.com
Layout table for additonal information
Responsible Party: Merck Sharp & Dohme Corp.
ClinicalTrials.gov Identifier: NCT00378599     History of Changes
Other Study ID Numbers: P04590
First Submitted: September 18, 2006
First Posted: September 20, 2006
Results First Submitted: June 17, 2010
Results First Posted: July 16, 2010
Last Update Posted: April 6, 2017