Trial Outcomes & Findings for Study of Response in Chronic Hepatitis C (CHC) Participants Genotype 1 With Insulin Resistance and Prolonged Treatment Duration in Late Responders (P04823/MK-4031-303) (NCT NCT00493805)
NCT ID: NCT00493805
Last Updated: 2017-04-07
Results Overview
Early Virological Response (EVR) defined as HCV PCR at Week 12 either negative or at least 2 log units less than baseline in participants with and without insulin resistance.
Recruitment status
TERMINATED
Study phase
PHASE4
Target enrollment
59 participants
Primary outcome timeframe
At Week 12 (after start of therapy)
Results posted on
2017-04-07
Participant Flow
Participant milestones
| Measure |
Non Interventional Arm HOMA IR <= 2
Participants in the non-interventional arm received PegIntron at a dose of 1.5 µg /kg based on the subject's body weight at baseline visit; administrated once weekly, subcutaneously (SC) for 48 weeks together with Rebetol at a dose of 800-1400 mg based on the subject's body weight at baseline visit; administered twice daily (BID), by mouth (PO) for 48 weeks (according to European labeling). Followed by a 24-week follow up period after end of treatment.
|
Interventional Arm HOMA IR > 2
Participants in the interventional arm received PegIntron at a dose of 1.5 µg /kg based on the subject's body weight at baseline visit; administrated once weekly, subcutaneously (SC) together with Rebetol at a dose of 800-1400 mg based on the subject's body weight at baseline visit; administered twice daily (BID), by mouth (PO) for 12-16 weeks until their HCV polymerase chain reaction (PCR) results are available at Week 12. At Week 12, participants with \>=2 log decrease of HCV RNA were randomized to continue either for another 36 weeks (Group A- a total of 48 weeks therapy) OR for another 60 weeks (Group B- a total of 72 weeks of therapy) with a 24-week follow up. Randomization was done between Day 1 Week 17 and Day 1 Week 25.
|
|---|---|---|
|
Overall Study
STARTED
|
17
|
42
|
|
Overall Study
COMPLETED
|
17
|
42
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Study of Response in Chronic Hepatitis C (CHC) Participants Genotype 1 With Insulin Resistance and Prolonged Treatment Duration in Late Responders (P04823/MK-4031-303)
Baseline characteristics by cohort
| Measure |
Total for Interventional Arm and Non Interventional Arm
n=59 Participants
|
|---|---|
|
Age, Customized
Between 18 and 65 years
|
59 Participants
n=5 Participants
|
|
Sex/Gender, Customized
Male
|
35 Participants
n=5 Participants
|
|
Sex/Gender, Customized
Female
|
24 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: At Week 12 (after start of therapy)Population: Interventional arm: At baseline, PCR measurements for 38 out of 42 participants were available. Non Interventional arm: At baseline, PCR measurements for 15 out of 17 participants were available.
Early Virological Response (EVR) defined as HCV PCR at Week 12 either negative or at least 2 log units less than baseline in participants with and without insulin resistance.
Outcome measures
| Measure |
Non Interventional Arm HOMA IR <= 2
n=15 Participants
Participants in the non-interventional arm received PegIntron at a dose of 1.5 µg /kg based on the subject's body weight at baseline visit; administrated once weekly, subcutaneously (SC) for 48 weeks together with Rebetol at a dose of 800-1400 mg based on the subject's body weight at baseline visit; administered twice daily (BID), by mouth (PO) for 48 weeks (according to European labeling). Followed by a 24-week follow up period after end of treatment.
|
Interventional Arm HOMA IR > 2
n=38 Participants
Participants in the interventional arm received PegIntron at a dose of 1.5 µg /kg based on the subject's body weight at baseline visit; administrated once weekly, subcutaneously (SC) together with Rebetol at a dose of 800-1400 mg based on the subject's body weight at baseline visit; administered twice daily (BID), by mouth (PO) for 12-16 weeks until their HCV polymerase chain reaction (PCR) results are available at Week 12. At Week 12, participants with \>=2 log decrease of HCV RNA were randomized to continue either for another 36 weeks (Group A- a total of 48 weeks therapy) OR for another 60 weeks (Group B- a total of 72 weeks of therapy) with a 24-week follow up. Randomization was done between Day 1 Week 17 and Day 1 Week 25.
|
|---|---|---|
|
Early Virological Response in Participants With and Without Insulin Resistance
|
10 Participants
|
24 Participants
|
SECONDARY outcome
Timeframe: Up to 24 weeks following 48 or 72 weeks of therapyPopulation: Information on PCR was available for 7 participants in the non interventional study arm and 11 participants in the interventional study arm.
Sustained virological response (SVR) was defined as undetectable HCV RNA in serum at the end of follow-up (24 weeks after end of therapy) according to a polymerase chain reaction (PCR) assay.
Outcome measures
| Measure |
Non Interventional Arm HOMA IR <= 2
n=7 Participants
Participants in the non-interventional arm received PegIntron at a dose of 1.5 µg /kg based on the subject's body weight at baseline visit; administrated once weekly, subcutaneously (SC) for 48 weeks together with Rebetol at a dose of 800-1400 mg based on the subject's body weight at baseline visit; administered twice daily (BID), by mouth (PO) for 48 weeks (according to European labeling). Followed by a 24-week follow up period after end of treatment.
|
Interventional Arm HOMA IR > 2
n=11 Participants
Participants in the interventional arm received PegIntron at a dose of 1.5 µg /kg based on the subject's body weight at baseline visit; administrated once weekly, subcutaneously (SC) together with Rebetol at a dose of 800-1400 mg based on the subject's body weight at baseline visit; administered twice daily (BID), by mouth (PO) for 12-16 weeks until their HCV polymerase chain reaction (PCR) results are available at Week 12. At Week 12, participants with \>=2 log decrease of HCV RNA were randomized to continue either for another 36 weeks (Group A- a total of 48 weeks therapy) OR for another 60 weeks (Group B- a total of 72 weeks of therapy) with a 24-week follow up. Randomization was done between Day 1 Week 17 and Day 1 Week 25.
|
|---|---|---|
|
Sustained Virological Response (PCR 24 Weeks After End of Treatment)
|
1 Participants
|
3 Participants
|
Adverse Events
Non Interventional Arm HOMA IR <=2
Serious events: 3 serious events
Other events: 15 other events
Deaths: 0 deaths
Interventional Arm HOMA IR >2
Serious events: 4 serious events
Other events: 37 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Non Interventional Arm HOMA IR <=2
n=17 participants at risk
|
Interventional Arm HOMA IR >2
n=42 participants at risk
|
|---|---|---|
|
Blood and lymphatic system disorders
ANAEMIA
|
5.9%
1/17 • Number of events 1
|
0.00%
0/42
|
|
Blood and lymphatic system disorders
NEUTROPENIA
|
5.9%
1/17 • Number of events 1
|
2.4%
1/42 • Number of events 1
|
|
Cardiac disorders
CORONARY ARTERY DISEASE
|
0.00%
0/17
|
2.4%
1/42 • Number of events 1
|
|
Endocrine disorders
HYPERTHYROIDISM
|
0.00%
0/17
|
2.4%
1/42 • Number of events 1
|
|
General disorders
NON-CARDIAC CHEST PAIN
|
0.00%
0/17
|
2.4%
1/42 • Number of events 1
|
|
Infections and infestations
GASTROENTERITIS
|
0.00%
0/17
|
2.4%
1/42 • Number of events 1
|
|
Psychiatric disorders
SUICIDE ATTEMPT
|
5.9%
1/17 • Number of events 1
|
0.00%
0/42
|
Other adverse events
| Measure |
Non Interventional Arm HOMA IR <=2
n=17 participants at risk
|
Interventional Arm HOMA IR >2
n=42 participants at risk
|
|---|---|---|
|
Blood and lymphatic system disorders
ANAEMIA
|
5.9%
1/17 • Number of events 4
|
23.8%
10/42 • Number of events 28
|
|
Blood and lymphatic system disorders
HAEMOGLOBINAEMIA
|
0.00%
0/17
|
7.1%
3/42 • Number of events 9
|
|
Blood and lymphatic system disorders
LEUKOPENIA
|
47.1%
8/17 • Number of events 14
|
31.0%
13/42 • Number of events 34
|
|
Blood and lymphatic system disorders
NEUTROPENIA
|
35.3%
6/17 • Number of events 13
|
28.6%
12/42 • Number of events 26
|
|
Blood and lymphatic system disorders
THROMBOCYTOPENIA
|
5.9%
1/17 • Number of events 1
|
4.8%
2/42 • Number of events 10
|
|
Cardiac disorders
TACHYCARDIA
|
5.9%
1/17 • Number of events 1
|
0.00%
0/42
|
|
Endocrine disorders
HYPOTHYROIDISM
|
0.00%
0/17
|
7.1%
3/42 • Number of events 3
|
|
Eye disorders
VISUAL ACUITY REDUCED
|
5.9%
1/17 • Number of events 1
|
0.00%
0/42
|
|
Gastrointestinal disorders
ABDOMINAL PAIN UPPER
|
0.00%
0/17
|
11.9%
5/42 • Number of events 6
|
|
Gastrointestinal disorders
CHAPPED LIPS
|
0.00%
0/17
|
7.1%
3/42 • Number of events 4
|
|
Gastrointestinal disorders
CHEILITIS
|
0.00%
0/17
|
11.9%
5/42 • Number of events 5
|
|
Gastrointestinal disorders
CONSTIPATION
|
5.9%
1/17 • Number of events 1
|
4.8%
2/42 • Number of events 2
|
|
Gastrointestinal disorders
DIARRHOEA
|
11.8%
2/17 • Number of events 2
|
7.1%
3/42 • Number of events 3
|
|
Gastrointestinal disorders
DRY MOUTH
|
0.00%
0/17
|
7.1%
3/42 • Number of events 3
|
|
Gastrointestinal disorders
GINGIVAL BLEEDING
|
5.9%
1/17 • Number of events 1
|
0.00%
0/42
|
|
Gastrointestinal disorders
NAUSEA
|
17.6%
3/17 • Number of events 4
|
19.0%
8/42 • Number of events 8
|
|
Gastrointestinal disorders
ORAL PAIN
|
5.9%
1/17 • Number of events 1
|
0.00%
0/42
|
|
Gastrointestinal disorders
VOMITING
|
0.00%
0/17
|
11.9%
5/42 • Number of events 5
|
|
General disorders
CHEST PAIN
|
11.8%
2/17 • Number of events 2
|
2.4%
1/42 • Number of events 1
|
|
General disorders
FATIGUE
|
11.8%
2/17 • Number of events 2
|
19.0%
8/42 • Number of events 8
|
|
General disorders
FEELING COLD
|
5.9%
1/17 • Number of events 1
|
0.00%
0/42
|
|
General disorders
INFLUENZA LIKE ILLNESS
|
29.4%
5/17 • Number of events 5
|
31.0%
13/42 • Number of events 14
|
|
General disorders
PAIN
|
5.9%
1/17 • Number of events 1
|
2.4%
1/42 • Number of events 1
|
|
General disorders
PYREXIA
|
17.6%
3/17 • Number of events 3
|
16.7%
7/42 • Number of events 12
|
|
Metabolism and nutrition disorders
DECREASED APPETITE
|
11.8%
2/17 • Number of events 2
|
9.5%
4/42 • Number of events 4
|
|
Musculoskeletal and connective tissue disorders
ARTHRALGIA
|
5.9%
1/17 • Number of events 1
|
7.1%
3/42 • Number of events 3
|
|
Musculoskeletal and connective tissue disorders
MYALGIA
|
17.6%
3/17 • Number of events 3
|
9.5%
4/42 • Number of events 4
|
|
Nervous system disorders
DYSGEUSIA
|
5.9%
1/17 • Number of events 1
|
0.00%
0/42
|
|
Nervous system disorders
HEADACHE
|
17.6%
3/17 • Number of events 3
|
33.3%
14/42 • Number of events 15
|
|
Nervous system disorders
HYPOTONIA
|
5.9%
1/17 • Number of events 1
|
0.00%
0/42
|
|
Nervous system disorders
SYNCOPE
|
11.8%
2/17 • Number of events 2
|
0.00%
0/42
|
|
Psychiatric disorders
DEPRESSION
|
23.5%
4/17 • Number of events 6
|
11.9%
5/42 • Number of events 5
|
|
Psychiatric disorders
DYSTHYMIC DISORDER
|
5.9%
1/17 • Number of events 1
|
0.00%
0/42
|
|
Psychiatric disorders
SLEEP DISORDER
|
17.6%
3/17 • Number of events 3
|
14.3%
6/42 • Number of events 7
|
|
Respiratory, thoracic and mediastinal disorders
ASTHMA
|
5.9%
1/17 • Number of events 1
|
0.00%
0/42
|
|
Respiratory, thoracic and mediastinal disorders
COUGH
|
11.8%
2/17 • Number of events 2
|
2.4%
1/42 • Number of events 1
|
|
Respiratory, thoracic and mediastinal disorders
DRY THROAT
|
5.9%
1/17 • Number of events 1
|
0.00%
0/42
|
|
Respiratory, thoracic and mediastinal disorders
DYSPNOEA
|
5.9%
1/17 • Number of events 1
|
4.8%
2/42 • Number of events 2
|
|
Respiratory, thoracic and mediastinal disorders
OROPHARYNGEAL PAIN
|
5.9%
1/17 • Number of events 1
|
0.00%
0/42
|
|
Skin and subcutaneous tissue disorders
ALOPECIA
|
23.5%
4/17 • Number of events 6
|
14.3%
6/42 • Number of events 6
|
|
Skin and subcutaneous tissue disorders
DRY SKIN
|
5.9%
1/17 • Number of events 1
|
14.3%
6/42 • Number of events 6
|
|
Skin and subcutaneous tissue disorders
ERYTHEMA
|
5.9%
1/17 • Number of events 1
|
0.00%
0/42
|
|
Skin and subcutaneous tissue disorders
NEURODERMATITIS
|
5.9%
1/17 • Number of events 1
|
0.00%
0/42
|
|
Skin and subcutaneous tissue disorders
PRURITUS
|
23.5%
4/17 • Number of events 5
|
26.2%
11/42 • Number of events 12
|
|
Skin and subcutaneous tissue disorders
RASH
|
5.9%
1/17 • Number of events 1
|
14.3%
6/42 • Number of events 6
|
|
Skin and subcutaneous tissue disorders
URTICARIA
|
11.8%
2/17 • Number of events 2
|
2.4%
1/42 • Number of events 1
|
|
Vascular disorders
POOR PERIPHERAL CIRCULATION
|
11.8%
2/17 • Number of events 2
|
0.00%
0/42
|
Additional Information
Senior Vice President, Global Clinical Development
Merck Sharp & Dohme Corp.
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place