Trial Outcomes & Findings for Peg-Intron/Ribavirin in G 1 HCV for Non-Extended Versus 24 Week Extended Treatment After 24 Weeks (Study P04144)(COMPLETED) (NCT NCT00202839)
NCT ID: NCT00202839
Last Updated: 2017-04-06
Results Overview
Sustained virologic response was defined as hepatitis C virus ribonucleic acid \[HCV-RNA\] levels below assay detection 24 weeks after termination of anti-HCV therapy
Recruitment status
COMPLETED
Study phase
PHASE4
Target enrollment
160 participants
Primary outcome timeframe
24 weeks of follow-up after either 24 or 48 weeks of anti-HCV therapy
Results posted on
2017-04-06
Participant Flow
Participant milestones
| Measure |
24-Week Treatment
Genotype 1 hepatitis C virus \[HCV\] subjects treated for a total of 24 weeks, during the pilot treatment program (immediately before randomization)
|
48-Week Treatment
Genotype 1 HCV subjects treated for a total of 48 weeks: 24 weeks during the pilot treatment program (immediately before randomization) plus 24 weeks during the extended treatment program (immediately after randomization)
|
|---|---|---|
|
Overall Study
STARTED
|
78
|
82
|
|
Overall Study
COMPLETED
|
54
|
72
|
|
Overall Study
NOT COMPLETED
|
24
|
10
|
Reasons for withdrawal
| Measure |
24-Week Treatment
Genotype 1 hepatitis C virus \[HCV\] subjects treated for a total of 24 weeks, during the pilot treatment program (immediately before randomization)
|
48-Week Treatment
Genotype 1 HCV subjects treated for a total of 48 weeks: 24 weeks during the pilot treatment program (immediately before randomization) plus 24 weeks during the extended treatment program (immediately after randomization)
|
|---|---|---|
|
Overall Study
Adverse Event
|
1
|
5
|
|
Overall Study
Physician Decision
|
12
|
0
|
|
Overall Study
Withdrawal by Subject
|
6
|
2
|
|
Overall Study
Protocol Violation
|
2
|
1
|
|
Overall Study
Lost to Follow-up
|
3
|
2
|
Baseline Characteristics
Peg-Intron/Ribavirin in G 1 HCV for Non-Extended Versus 24 Week Extended Treatment After 24 Weeks (Study P04144)(COMPLETED)
Baseline characteristics by cohort
| Measure |
24-Week Treatment
n=78 Participants
Genotype 1 hepatitis C virus \[HCV\] subjects treated for a total of 24 weeks, during the pilot treatment program (immediately before randomization)
|
48-Week Treatment
n=82 Participants
Genotype 1 HCV subjects treated for a total of 48 weeks: 24 weeks during the pilot treatment program (immediately before randomization) plus 24 weeks during the extended treatment program (immediately after randomization)
|
Total
n=160 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
50.63 years
STANDARD_DEVIATION 10.6 • n=5 Participants
|
50.46 years
STANDARD_DEVIATION 10.93 • n=7 Participants
|
50.55 years
STANDARD_DEVIATION 10.74 • n=5 Participants
|
|
Sex: Female, Male
Female
|
20 Participants
n=5 Participants
|
39 Participants
n=7 Participants
|
59 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
58 Participants
n=5 Participants
|
43 Participants
n=7 Participants
|
101 Participants
n=5 Participants
|
|
Region of Enrollment
Taiwan, Province Of China
|
78 participants
n=5 Participants
|
82 participants
n=7 Participants
|
160 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: 24 weeks of follow-up after either 24 or 48 weeks of anti-HCV therapyPopulation: Intention to treat \[ITT\] population defined as participants who received at least one dose of study medication.
Sustained virologic response was defined as hepatitis C virus ribonucleic acid \[HCV-RNA\] levels below assay detection 24 weeks after termination of anti-HCV therapy
Outcome measures
| Measure |
24-Week Treatment
n=78 Participants
Genotype 1 hepatitis C virus \[HCV\] subjects treated for a total of 24 weeks, during the pilot treatment program (immediately before randomization)
|
48-Week Treatment
n=82 Participants
Genotype 1 HCV subjects treated for a total of 48 weeks: 24 weeks during the pilot treatment program (immediately before randomization) plus 24 weeks during the extended treatment program (immediately after randomization)
|
|---|---|---|
|
The Percentage of Participants Who Achieved a Sustained Virologic Response (SVR)
|
56.41 Percentage of participants
|
67.07 Percentage of participants
|
SECONDARY outcome
Timeframe: 48 weeks after randomization (with 24 weeks of treatment immediately before randomization and either 0 or 24 weeks of treatment immediately after randomization)Population: Intention to treat \[ITT\] population
Virologic response was defined as undetectable HCV-RNA level in the blood.
Outcome measures
| Measure |
24-Week Treatment
n=78 Participants
Genotype 1 hepatitis C virus \[HCV\] subjects treated for a total of 24 weeks, during the pilot treatment program (immediately before randomization)
|
48-Week Treatment
n=82 Participants
Genotype 1 HCV subjects treated for a total of 48 weeks: 24 weeks during the pilot treatment program (immediately before randomization) plus 24 weeks during the extended treatment program (immediately after randomization)
|
|---|---|---|
|
The Percentage of Participants Who Achieved a Virologic Response 48 Weeks After Randomization.
|
57.69 Percentage of Participants
|
67.07 Percentage of Participants
|
Adverse Events
24-Week Treatment
Serious events: 5 serious events
Other events: 29 other events
Deaths: 0 deaths
48-Week Treatment
Serious events: 8 serious events
Other events: 47 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
24-Week Treatment
n=78 participants at risk
|
48-Week Treatment
n=82 participants at risk
|
|---|---|---|
|
Ear and labyrinth disorders
EAR PAIN
|
0.00%
0/78
|
1.2%
1/82 • Number of events 1
|
|
Gastrointestinal disorders
ABDOMINAL PAIN LOWER
|
0.00%
0/78
|
1.2%
1/82 • Number of events 1
|
|
Gastrointestinal disorders
DYSPEPSIA
|
0.00%
0/78
|
1.2%
1/82 • Number of events 1
|
|
Gastrointestinal disorders
PANCREATITIS ACUTE
|
0.00%
0/78
|
1.2%
1/82 • Number of events 1
|
|
General disorders
LOCAL SWELLING
|
0.00%
0/78
|
1.2%
1/82 • Number of events 1
|
|
General disorders
NODULE
|
1.3%
1/78 • Number of events 1
|
0.00%
0/82
|
|
Hepatobiliary disorders
CHOLECYSTITIS
|
1.3%
1/78 • Number of events 1
|
0.00%
0/82
|
|
Hepatobiliary disorders
CHOLELITHIASIS
|
0.00%
0/78
|
2.4%
2/82 • Number of events 2
|
|
Infections and infestations
TONSILLITIS
|
1.3%
1/78 • Number of events 1
|
0.00%
0/82
|
|
Injury, poisoning and procedural complications
HEAD INJURY
|
1.3%
1/78 • Number of events 1
|
0.00%
0/82
|
|
Injury, poisoning and procedural complications
LIMB INJURY
|
1.3%
1/78 • Number of events 1
|
0.00%
0/82
|
|
Investigations
BLOOD GLUCOSE ABNORMAL
|
1.3%
1/78 • Number of events 1
|
0.00%
0/82
|
|
Investigations
SEVERE THROMBOCYTOPENIA
|
0.00%
0/78
|
1.2%
1/82 • Number of events 1
|
|
Musculoskeletal and connective tissue disorders
FISTULA DISCHARGE
|
0.00%
0/78
|
1.2%
1/82 • Number of events 1
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
HEPATIC NEOPLASM MALIGNANT
|
0.00%
0/78
|
1.2%
1/82 • Number of events 1
|
|
Respiratory, thoracic and mediastinal disorders
DYSPNOEA
|
1.3%
1/78 • Number of events 1
|
0.00%
0/82
|
Other adverse events
| Measure |
24-Week Treatment
n=78 participants at risk
|
48-Week Treatment
n=82 participants at risk
|
|---|---|---|
|
Endocrine disorders
THYROID DISORDER
|
2.6%
2/78 • Number of events 3
|
6.1%
5/82 • Number of events 8
|
|
General disorders
FATIGUE
|
5.1%
4/78 • Number of events 4
|
6.1%
5/82 • Number of events 7
|
|
General disorders
INFLUENZA LIKE ILLNESS
|
0.00%
0/78
|
9.8%
8/82 • Number of events 9
|
|
General disorders
MALAISE
|
3.8%
3/78 • Number of events 3
|
6.1%
5/82 • Number of events 7
|
|
General disorders
PYREXIA
|
0.00%
0/78
|
9.8%
8/82 • Number of events 11
|
|
Infections and infestations
NASOPHARYNGITIS
|
5.1%
4/78 • Number of events 5
|
2.4%
2/82 • Number of events 2
|
|
Investigations
ALANINE AMINOTRANSFERASE ABNORMAL
|
6.4%
5/78 • Number of events 8
|
1.2%
1/82 • Number of events 1
|
|
Investigations
ALANINE AMINOTRANSFERASE INCREASED
|
5.1%
4/78 • Number of events 5
|
1.2%
1/82 • Number of events 1
|
|
Investigations
ASPARTATE AMINOTRANSFERASE INCREASED
|
5.1%
4/78 • Number of events 5
|
1.2%
1/82 • Number of events 1
|
|
Investigations
HAEMOGLOBIN ABNORMAL
|
0.00%
0/78
|
11.0%
9/82 • Number of events 9
|
|
Metabolism and nutrition disorders
ANOREXIA
|
0.00%
0/78
|
6.1%
5/82 • Number of events 5
|
|
Metabolism and nutrition disorders
TYPE 2 DIABETES MELLITUS
|
7.7%
6/78 • Number of events 6
|
1.2%
1/82 • Number of events 1
|
|
Nervous system disorders
HEADACHE
|
3.8%
3/78 • Number of events 3
|
7.3%
6/82 • Number of events 7
|
|
Psychiatric disorders
INSOMNIA
|
10.3%
8/78 • Number of events 8
|
13.4%
11/82 • Number of events 16
|
|
Respiratory, thoracic and mediastinal disorders
COUGH
|
3.8%
3/78 • Number of events 3
|
7.3%
6/82 • Number of events 6
|
|
Skin and subcutaneous tissue disorders
PRURITUS
|
2.6%
2/78 • Number of events 2
|
11.0%
9/82 • Number of events 10
|
|
Skin and subcutaneous tissue disorders
RASH
|
0.00%
0/78
|
7.3%
6/82 • Number of events 7
|
Additional Information
Senior Vice President, Global Clinical Development
Merck Sharp & Dohme Corp
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee Principal Investigator and Institution further agree to provide forty-five (45) days written notice to Sponsor prior to submission for publication or presentation to permit Sponsor to review drafts of abstracts and manuscripts for publication.
- Publication restrictions are in place
Restriction type: OTHER