Trial Outcomes & Findings for Treatment of Patients With Chronic Hepatitis C With PegIntron as Monotherapy or in Combination With Ribavirin (Study P04437)(COMPLETED) (NCT NCT00705666)
NCT ID: NCT00705666
Last Updated: 2015-10-02
Results Overview
Recruitment status
COMPLETED
Target enrollment
789 participants
Primary outcome timeframe
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.
Results posted on
2015-10-02
Participant Flow
Participant milestones
| Measure |
PegIntron as Monotherapy or in Combination With Ribavirin
Adult participants with chronic hepatitis C treated with PegIntron as monotherapy or in combination with ribavirin.
|
|---|---|
|
Overall Study
STARTED
|
789
|
|
Overall Study
COMPLETED
|
450
|
|
Overall Study
NOT COMPLETED
|
339
|
Reasons for withdrawal
| Measure |
PegIntron as Monotherapy or in Combination With Ribavirin
Adult participants with chronic hepatitis C treated with PegIntron as monotherapy or in combination with ribavirin.
|
|---|---|
|
Overall Study
No post-treatment questionnaire
|
279
|
|
Overall Study
Withdrawal by Subject
|
21
|
|
Overall Study
Physician Decision
|
7
|
|
Overall Study
Lost to Follow-up
|
5
|
|
Overall Study
Death
|
1
|
|
Overall Study
Adverse Event
|
4
|
|
Overall Study
Other
|
2
|
|
Overall Study
Lack of data
|
3
|
|
Overall Study
Untreated
|
5
|
Baseline Characteristics
Treatment of Patients With Chronic Hepatitis C With PegIntron as Monotherapy or in Combination With Ribavirin (Study P04437)(COMPLETED)
Baseline characteristics by cohort
| Measure |
PegIntron as Monotherapy or in Combination With Ribavirin
n=789 Participants
Adult participants with chronic hepatitis C treated with PegIntron as monotherapy or in combination with ribavirin.
|
|---|---|
|
Age, Customized
|
49 years
STANDARD_DEVIATION 12.1 • n=5 Participants
|
|
Sex/Gender, Customized
Female
|
296 participants
n=5 Participants
|
|
Sex/Gender, Customized
Male
|
485 participants
n=5 Participants
|
|
Sex/Gender, Customized
Unavailable
|
8 participants
n=5 Participants
|
|
Region of Enrollment
France
|
789 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: 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.Population: 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).
Outcome measures
| Measure |
PegIntron as Monotherapy or in Combination With Ribavirin
n=781 Participants
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.
|
|---|---|
|
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).
G2, 3 completing 24 weeks of treatment
|
160 Participants
|
|
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).
G 1, 4, others completing 48 weeks of treatment
|
195 Participants
|
Adverse Events
PegIntron as Monotherapy or in Combination With Ribavirin
Serious events: 66 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
PegIntron as Monotherapy or in Combination With Ribavirin
n=789 participants at risk
|
|---|---|
|
Blood and lymphatic system disorders
ANAEMIA
|
0.76%
6/789 • Number of events 6
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.
|
|
Blood and lymphatic system disorders
ANAEMIA MACROCYTIC
|
0.13%
1/789 • Number of events 1
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.
|
|
Blood and lymphatic system disorders
HAEMOLYTIC ANAEMIA
|
0.25%
2/789 • Number of events 2
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.
|
|
Blood and lymphatic system disorders
HYPERSPLENISM
|
0.13%
1/789 • Number of events 1
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.
|
|
Blood and lymphatic system disorders
LEUKOPENIA
|
0.13%
1/789 • Number of events 1
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.
|
|
Blood and lymphatic system disorders
NEUTROPENIA
|
0.13%
1/789 • Number of events 1
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.
|
|
Blood and lymphatic system disorders
PANCYTOPENIA
|
0.13%
1/789 • Number of events 1
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.
|
|
Blood and lymphatic system disorders
THROMBOCYTOPENIA
|
0.25%
2/789 • Number of events 2
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.
|
|
Blood and lymphatic system disorders
THROMBOCYTOPENIC PURPURA
|
0.13%
1/789 • Number of events 1
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.
|
|
Cardiac disorders
ANGINA PECTORIS
|
0.13%
1/789 • Number of events 1
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.
|
|
Cardiac disorders
CARDIAC DISORDER
|
0.13%
1/789 • Number of events 1
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.
|
|
Cardiac disorders
CARDIAC FAILURE
|
0.13%
1/789 • Number of events 1
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.
|
|
Cardiac disorders
CORONARY ARTERY INSUFFICIENCY
|
0.13%
1/789 • Number of events 1
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.
|
|
Cardiac disorders
SINUS TACHYCARDIA
|
0.13%
1/789 • Number of events 1
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.
|
|
Ear and labyrinth disorders
OTOTOXICITY
|
0.13%
1/789 • Number of events 1
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.
|
|
Endocrine disorders
HYPERTHYROIDISM
|
0.38%
3/789 • Number of events 3
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.
|
|
Endocrine disorders
HYPOTHYROIDISM
|
0.13%
1/789 • Number of events 1
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.
|
|
Eye disorders
CONJUNCTIVITIS
|
0.13%
1/789 • Number of events 1
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.
|
|
Eye disorders
IRIDOCYCLITIS
|
0.13%
1/789 • Number of events 1
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.
|
|
Eye disorders
OCULAR HYPERTENSION
|
0.13%
1/789 • Number of events 1
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.
|
|
Eye disorders
RETINAL VEIN OCCLUSION
|
0.13%
1/789 • Number of events 1
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.
|
|
Gastrointestinal disorders
ABDOMINAL PAIN
|
0.13%
1/789 • Number of events 1
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.
|
|
Gastrointestinal disorders
ASCITES
|
0.13%
1/789 • Number of events 1
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.
|
|
Gastrointestinal disorders
DIARRHOEA
|
0.13%
1/789 • Number of events 1
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.
|
|
Gastrointestinal disorders
GASTROINTESTINAL HAEMORRHAGE
|
0.51%
4/789 • Number of events 4
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.
|
|
General disorders
ASTHENIA
|
0.13%
1/789 • Number of events 1
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.
|
|
General disorders
PYREXIA
|
0.13%
1/789 • Number of events 1
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.
|
|
Hepatobiliary disorders
CHOLANGITIS
|
0.13%
1/789 • Number of events 1
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.
|
|
Hepatobiliary disorders
CHOLELITHIASIS
|
0.13%
1/789 • Number of events 1
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.
|
|
Hepatobiliary disorders
HEPATOTOXICITY
|
0.13%
1/789 • Number of events 1
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.
|
|
Hepatobiliary disorders
PORTAL HYPERTENSION
|
0.13%
1/789 • Number of events 1
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.
|
|
Hepatobiliary disorders
PORTAL VEIN THROMBOSIS
|
0.13%
1/789 • Number of events 1
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.
|
|
Immune system disorders
AUTOIMMUNE DISORDER
|
0.13%
1/789 • Number of events 1
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.
|
|
Infections and infestations
INJECTION SITE ABSCESS
|
0.13%
1/789 • Number of events 1
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.
|
|
Infections and infestations
RECTAL ABSCESS
|
0.13%
1/789 • Number of events 1
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.
|
|
Infections and infestations
STAPHYLOCOCCAL SEPSIS
|
0.13%
1/789 • Number of events 1
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.
|
|
Infections and infestations
SUPERINFECTION
|
0.13%
1/789 • Number of events 1
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.
|
|
Injury, poisoning and procedural complications
ANIMAL BITE
|
0.13%
1/789 • Number of events 1
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.
|
|
Injury, poisoning and procedural complications
INTENTIONAL OVERDOSE
|
0.13%
1/789 • Number of events 1
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.
|
|
Injury, poisoning and procedural complications
PATERNAL DRUGS AFFECTING FOETUS
|
0.13%
1/789 • Number of events 1
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.
|
|
Injury, poisoning and procedural complications
SPLENIC RUPTURE
|
0.13%
1/789 • Number of events 1
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.
|
|
Investigations
BIOPSY LIVER
|
0.13%
1/789 • Number of events 1
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.
|
|
Investigations
ENDOSCOPY GASTROINTESTINAL NORMAL
|
0.13%
1/789 • Number of events 1
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.
|
|
Metabolism and nutrition disorders
DIABETES MELLITUS
|
0.13%
1/789 • Number of events 1
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.
|
|
Metabolism and nutrition disorders
DIABETIC COMPLICATION
|
0.13%
1/789 • Number of events 1
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.
|
|
Metabolism and nutrition disorders
TYPE 1 DIABETES MELLITUS
|
0.13%
1/789 • Number of events 1
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.
|
|
Musculoskeletal and connective tissue disorders
PSORIATIC ARTHROPATHY
|
0.13%
1/789 • Number of events 1
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.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
HEPATIC NEOPLASM MALIGNANT
|
0.25%
2/789 • Number of events 2
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.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
LIP AND/OR ORAL CAVITY CANCER
|
0.13%
1/789 • Number of events 1
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.
|
|
Nervous system disorders
COMA
|
0.13%
1/789 • Number of events 1
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.
|
|
Nervous system disorders
EPILEPSY
|
0.13%
1/789 • Number of events 1
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.
|
|
Nervous system disorders
TREMOR
|
0.13%
1/789 • Number of events 1
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.
|
|
Psychiatric disorders
ANXIETY
|
0.13%
1/789 • Number of events 1
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.
|
|
Psychiatric disorders
COMPLETED SUICIDE
|
0.38%
3/789 • Number of events 3
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.
|
|
Psychiatric disorders
DELUSION
|
0.38%
3/789 • Number of events 3
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.
|
|
Psychiatric disorders
DEPRESSION
|
1.0%
8/789 • Number of events 8
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.
|
|
Psychiatric disorders
DEPRESSION SUICIDAL
|
0.13%
1/789 • Number of events 1
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.
|
|
Psychiatric disorders
MAJOR DEPRESSION
|
0.13%
1/789 • Number of events 1
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.
|
|
Psychiatric disorders
NERVOUSNESS
|
0.13%
1/789 • Number of events 1
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.
|
|
Psychiatric disorders
PARANOIA
|
0.13%
1/789 • Number of events 1
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.
|
|
Psychiatric disorders
PSYCHOTIC DISORDER
|
0.13%
1/789 • Number of events 1
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.
|
|
Psychiatric disorders
SUICIDAL IDEATION
|
0.25%
2/789 • Number of events 2
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.
|
|
Psychiatric disorders
SUICIDE ATTEMPT
|
0.25%
2/789 • Number of events 2
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.
|
|
Renal and urinary disorders
HAEMATURIA
|
0.13%
1/789 • Number of events 1
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.
|
|
Respiratory, thoracic and mediastinal disorders
CHRONIC OBSTRUCTIVE PULMONARY DISEASE
|
0.13%
1/789 • Number of events 1
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.
|
|
Respiratory, thoracic and mediastinal disorders
COUGH
|
0.13%
1/789 • Number of events 1
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.
|
|
Respiratory, thoracic and mediastinal disorders
DYSPNOEA
|
0.13%
1/789 • Number of events 1
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.
|
|
Respiratory, thoracic and mediastinal disorders
EPISTAXIS
|
0.13%
1/789 • Number of events 1
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.
|
|
Respiratory, thoracic and mediastinal disorders
HAEMOPTYSIS
|
0.25%
2/789 • Number of events 2
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.
|
|
Respiratory, thoracic and mediastinal disorders
PRODUCTIVE COUGH
|
0.13%
1/789 • Number of events 1
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.
|
|
Respiratory, thoracic and mediastinal disorders
PULMONARY FIBROSIS
|
0.13%
1/789 • Number of events 1
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.
|
|
Respiratory, thoracic and mediastinal disorders
RESPIRATORY FAILURE
|
0.13%
1/789 • Number of events 1
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.
|
|
Skin and subcutaneous tissue disorders
SKIN ULCER
|
0.13%
1/789 • Number of events 1
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.
|
|
Surgical and medical procedures
ALCOHOL DETOXIFICATION
|
0.38%
3/789 • Number of events 3
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.
|
|
Surgical and medical procedures
HOSPITALISATION
|
0.13%
1/789 • Number of events 1
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.
|
|
Vascular disorders
PHLEBITIS
|
0.13%
1/789 • Number of events 1
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.
|
Other adverse events
Adverse event data not reported
Additional Information
Senior Vice President, Global Clinical Development
Merck Sharp & Dohme Corp.
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee Any published results concerning the data of the non-interventional study is forbidden. Study data and results are exclusive property of the sponsor.
- Publication restrictions are in place
Restriction type: OTHER