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Treatment of Patients With Chronic Hepatitis C With PegIntron as Monotherapy or in Combination With Ribavirin (Study P04437)(COMPLETED) (ADEQUATION)

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: NCT00705666
Recruitment Status : Completed
First Posted : June 26, 2008
Results First Posted : June 24, 2010
Last Update Posted : October 2, 2015
Sponsor:
Information provided by (Responsible Party):
Merck Sharp & Dohme Corp.

Study Type Observational
Study Design Observational Model: Cohort;   Time Perspective: Prospective
Conditions Hepatitis C, Chronic
Hepacivirus
Interventions Biological: Peginterferon alfa-2b (SCH 54031)
Drug: Ribavirin (SCH 18908)
Enrollment 789
Recruitment Details  
Pre-assignment Details  
Arm/Group Title PegIntron as Monotherapy or in Combination With Ribavirin
Hide Arm/Group Description Adult participants with chronic hepatitis C treated with PegIntron as monotherapy or in combination with ribavirin.
Period Title: Overall Study
Started 789
Completed 450
Not Completed 339
Reason Not Completed
No post-treatment questionnaire             279
Withdrawal by Subject             21
Physician Decision             7
Lost to Follow-up             5
Death             1
Adverse Event             4
Other             12
Other             2
Lack of data             3
Untreated             5
Arm/Group Title PegIntron as Monotherapy or in Combination With Ribavirin
Hide Arm/Group Description Adult participants with chronic hepatitis C treated with PegIntron as monotherapy or in combination with ribavirin.
Overall Number of Baseline Participants 789
Hide Baseline Analysis Population Description
[Not Specified]
Age, Customized  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 789 participants
49  (12.1)
Sex/Gender, Customized   [1] 
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 789 participants
Female 296
Male 485
Unavailable 8
[1]
Measure Description: Gender is provided for the patients that were included in the analysis (781); gender is unknown for the eight (8) participants that were not included in the analysis.
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
France Number Analyzed 789 participants
789
1.Primary Outcome
Title The Number of Participants Receiving the Recommended Treatment Duration (24 Weeks for Genotypes 2 and 3 and 48 Weeks for Genotype 1 According to the French 2002 Consensus Meeting).
Hide Description [Not Specified]
Time Frame Physicians will complete a questionnaire at these visits: treatment initiation; 12 and 24 weeks after treatment initiation and 24 weeks after the end of treatment; and 36 and 48 weeks after treatment initiation for participants treated for 48 weeks.
Hide Outcome Measure Data
Hide Analysis Population Description
For the 48 week treatment period, the analysis did not separate Genotype 1 (G1) from Genotype 4 (G4) or others. Of the 789 participants, 8 were excluded from analysis (3 for lack of data; 5 because they were untreated).
Arm/Group Title PegIntron as Monotherapy or in Combination With Ribavirin
Hide Arm/Group Description:

Adult participants with chronic hepatitis C treated with PegIntron as monotherapy or in combination with ribavirin.

The recommended treatment duration was 24 weeks for genotypes 2 and 3 and 48 weeks for genotype 1 according to the French 2002 consensus meeting.

The start and end dates of the treatment were collected in the questionnaire, so the actual treatment duration was calculated for each participant and compared to the theoretical treatment duration reported at Day 0 by the investigators.

Overall Number of Participants Analyzed 781
Measure Type: Number
Unit of Measure: Participants
G2, 3 completing 24 weeks of treatment 160
G 1, 4, others completing 48 weeks of treatment 195
Time Frame [Not Specified]
Adverse Event Reporting Description Per protocol, adverse events were not collected; therefore, they were not reported. Serious Adverse Event (SAE) cases were reported by the investigators to the safety department and reported below.
 
Arm/Group Title PegIntron as Monotherapy or in Combination With Ribavirin
Hide Arm/Group Description [Not Specified]
All-Cause Mortality
PegIntron as Monotherapy or in Combination With Ribavirin
Affected / at Risk (%)
Total   --/--    
Hide Serious Adverse Events
PegIntron as Monotherapy or in Combination With Ribavirin
Affected / at Risk (%) # Events
Total   66/789 (8.37%)    
Blood and lymphatic system disorders   
ANAEMIA  1  6/789 (0.76%)  6
ANAEMIA MACROCYTIC  1  1/789 (0.13%)  1
HAEMOLYTIC ANAEMIA  1  2/789 (0.25%)  2
HYPERSPLENISM  1  1/789 (0.13%)  1
LEUKOPENIA  1  1/789 (0.13%)  1
NEUTROPENIA  1  1/789 (0.13%)  1
PANCYTOPENIA  1  1/789 (0.13%)  1
THROMBOCYTOPENIA  1  2/789 (0.25%)  2
THROMBOCYTOPENIC PURPURA  1  1/789 (0.13%)  1
Cardiac disorders   
ANGINA PECTORIS  1  1/789 (0.13%)  1
CARDIAC DISORDER  1  1/789 (0.13%)  1
CARDIAC FAILURE  1  1/789 (0.13%)  1
CORONARY ARTERY INSUFFICIENCY  1  1/789 (0.13%)  1
SINUS TACHYCARDIA  1  1/789 (0.13%)  1
Ear and labyrinth disorders   
OTOTOXICITY  1  1/789 (0.13%)  1
Endocrine disorders   
HYPERTHYROIDISM  1  3/789 (0.38%)  3
HYPOTHYROIDISM  1  1/789 (0.13%)  1
Eye disorders   
CONJUNCTIVITIS  1  1/789 (0.13%)  1
IRIDOCYCLITIS  1  1/789 (0.13%)  1
OCULAR HYPERTENSION  1  1/789 (0.13%)  1
RETINAL VEIN OCCLUSION  1  1/789 (0.13%)  1
Gastrointestinal disorders   
ABDOMINAL PAIN  1  1/789 (0.13%)  1
ASCITES  1  1/789 (0.13%)  1
DIARRHOEA  1  1/789 (0.13%)  1
GASTROINTESTINAL HAEMORRHAGE  1  4/789 (0.51%)  4
General disorders   
ASTHENIA  1  1/789 (0.13%)  1
PYREXIA  1  1/789 (0.13%)  1
Hepatobiliary disorders   
CHOLANGITIS  1  1/789 (0.13%)  1
CHOLELITHIASIS  1  1/789 (0.13%)  1
HEPATOTOXICITY  1  1/789 (0.13%)  1
PORTAL HYPERTENSION  1  1/789 (0.13%)  1
PORTAL VEIN THROMBOSIS  1  1/789 (0.13%)  1
Immune system disorders   
AUTOIMMUNE DISORDER  1  1/789 (0.13%)  1
Infections and infestations   
INJECTION SITE ABSCESS  1  1/789 (0.13%)  1
RECTAL ABSCESS  1  1/789 (0.13%)  1
STAPHYLOCOCCAL SEPSIS  1  1/789 (0.13%)  1
SUPERINFECTION  1  1/789 (0.13%)  1
Injury, poisoning and procedural complications   
ANIMAL BITE  1  1/789 (0.13%)  1
INTENTIONAL OVERDOSE  1  1/789 (0.13%)  1
PATERNAL DRUGS AFFECTING FOETUS  1  1/789 (0.13%)  1
SPLENIC RUPTURE  1  1/789 (0.13%)  1
Investigations   
BIOPSY LIVER  1  1/789 (0.13%)  1
ENDOSCOPY GASTROINTESTINAL NORMAL  1  1/789 (0.13%)  1
Metabolism and nutrition disorders   
DIABETES MELLITUS  1  1/789 (0.13%)  1
DIABETIC COMPLICATION  1  1/789 (0.13%)  1
TYPE 1 DIABETES MELLITUS  1  1/789 (0.13%)  1
Musculoskeletal and connective tissue disorders   
PSORIATIC ARTHROPATHY  1  1/789 (0.13%)  1
Neoplasms benign, malignant and unspecified (incl cysts and polyps)   
HEPATIC NEOPLASM MALIGNANT  1  2/789 (0.25%)  2
LIP AND/OR ORAL CAVITY CANCER  1  1/789 (0.13%)  1
Nervous system disorders   
COMA  1  1/789 (0.13%)  1
EPILEPSY  1  1/789 (0.13%)  1
TREMOR  1  1/789 (0.13%)  1
Psychiatric disorders   
ANXIETY  1  1/789 (0.13%)  1
COMPLETED SUICIDE  1  3/789 (0.38%)  3
DELUSION  1  3/789 (0.38%)  3
DEPRESSION  1  8/789 (1.01%)  8
DEPRESSION SUICIDAL  1  1/789 (0.13%)  1
MAJOR DEPRESSION  1  1/789 (0.13%)  1
NERVOUSNESS  1  1/789 (0.13%)  1
PARANOIA  1  1/789 (0.13%)  1
PSYCHOTIC DISORDER  1  1/789 (0.13%)  1
SUICIDAL IDEATION  1  2/789 (0.25%)  2
SUICIDE ATTEMPT  1  2/789 (0.25%)  2
Renal and urinary disorders   
HAEMATURIA  1  1/789 (0.13%)  1
Respiratory, thoracic and mediastinal disorders   
CHRONIC OBSTRUCTIVE PULMONARY DISEASE  1  1/789 (0.13%)  1
COUGH  1  1/789 (0.13%)  1
DYSPNOEA  1  1/789 (0.13%)  1
EPISTAXIS  1  1/789 (0.13%)  1
HAEMOPTYSIS  1  2/789 (0.25%)  2
PRODUCTIVE COUGH  1  1/789 (0.13%)  1
PULMONARY FIBROSIS  1  1/789 (0.13%)  1
RESPIRATORY FAILURE  1  1/789 (0.13%)  1
Skin and subcutaneous tissue disorders   
SKIN ULCER  1  1/789 (0.13%)  1
Surgical and medical procedures   
ALCOHOL DETOXIFICATION  1  3/789 (0.38%)  3
HOSPITALISATION  1  1/789 (0.13%)  1
Vascular disorders   
PHLEBITIS  1  1/789 (0.13%)  1
Indicates events were collected by systematic assessment
1
Term from vocabulary, MedDRA 12.0
Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
PegIntron as Monotherapy or in Combination With Ribavirin
Affected / at Risk (%) # Events
Total   0/0    
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.
Any published results concerning the data of the non-interventional study is forbidden. Study data and results are exclusive property of the sponsor.
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: NCT00705666    
Other Study ID Numbers: P04437
First Submitted: June 23, 2008
First Posted: June 26, 2008
Results First Submitted: March 30, 2010
Results First Posted: June 24, 2010
Last Update Posted: October 2, 2015