Trial Outcomes & Findings for Alisporivir (Deb025) and Boceprevir Triple Therapies in African American Participants Not Previously Treated for Chronic Hepatitis C Genotype 1 (NCT NCT01446250)
NCT ID: NCT01446250
Last Updated: 2017-01-16
Results Overview
Recruitment status
TERMINATED
Study phase
PHASE3
Target enrollment
8 participants
Primary outcome timeframe
within 48 weeks
Results posted on
2017-01-16
Participant Flow
Participant milestones
| Measure |
Alisporivir
Participants randomized to Treatment A and B received Alisporivir (ALV) 400 mg twice daily (BID) with Peginterferon alfa-2a (PEGinf) and Ribavirin (RBV) in Treatment Period 1.
|
Boceprevir
Participants randomized to Treatment C received Boceprevir (BOC) 800 mg three times daily (TID) with PEGinf and RBV in Treatment Period 1. Participants who received ALV in Treatment Period 1 and were put on clinical hold for 4 weeks, received BOC 800 mg TID with PEGinf and RBV in Treatment Period 2.
|
PEGinf + RBV
Participants who received ALV in Treatment Period 1 were put on clinical hold but continued receiving PEGinf and RBV for 4 weeks, after which they switched to BOC triple therapy in Treatment Period 2.
|
No Intervention
Participants who had an End of Treatment Response (ETR) were followed-up for 24 weeks after the last dose of BOC triple therapy (in Treatment Period 2) and participants who did not respond for any reason or discontinued the treatment early were followed-up for 12 weeks after the last dose of BOC (in Treatment Period 2).
|
|---|---|---|---|---|
|
Treatment Period 1
STARTED
|
5
|
3
|
0
|
0
|
|
Treatment Period 1
COMPLETED
|
5
|
2
|
0
|
0
|
|
Treatment Period 1
NOT COMPLETED
|
0
|
1
|
0
|
0
|
|
Clinical Hold
STARTED
|
0
|
2
|
5
|
0
|
|
Clinical Hold
COMPLETED
|
0
|
2
|
5
|
0
|
|
Clinical Hold
NOT COMPLETED
|
0
|
0
|
0
|
0
|
|
Treatment Period 2
STARTED
|
0
|
7
|
0
|
0
|
|
Treatment Period 2
COMPLETED
|
0
|
6
|
0
|
0
|
|
Treatment Period 2
NOT COMPLETED
|
0
|
1
|
0
|
0
|
|
Follow-up
STARTED
|
0
|
0
|
0
|
6
|
|
Follow-up
COMPLETED
|
0
|
0
|
0
|
0
|
|
Follow-up
NOT COMPLETED
|
0
|
0
|
0
|
6
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Alisporivir (Deb025) and Boceprevir Triple Therapies in African American Participants Not Previously Treated for Chronic Hepatitis C Genotype 1
Baseline characteristics by cohort
| Measure |
All Enrolled Participants
n=8 Participants
Analysis was performed on all enrolled participants.
|
|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=5 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
8 Participants
n=5 Participants
|
|
Age, Categorical
>=65 years
|
0 Participants
n=5 Participants
|
|
Gender
Female
|
5 Participants
n=5 Participants
|
|
Gender
Male
|
3 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: within 48 weeksPopulation: No data has been reported because planned data analyses were not performed as the study was terminated before the outcome measure time point.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: within 48 weeksPopulation: No data has been reported because planned data analyses were not performed as the study was terminated before the outcome measure time point.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: 24 weeks post-treatmentPopulation: No data has been reported because planned data analyses were not performed as the study was terminated before the outcome measure time point.
SVR24 was defined as hepatitis C virus (HCV) RNA undetectable (by limit of detection) 24 weeks after end of treatment.
Outcome measures
Outcome data not reported
Adverse Events
Alisporivir
Serious events: 0 serious events
Other events: 5 other events
Deaths: 0 deaths
Boceprevir
Serious events: 1 serious events
Other events: 8 other events
Deaths: 0 deaths
PEGinf + RBV
Serious events: 0 serious events
Other events: 4 other events
Deaths: 0 deaths
No Intervention
Serious events: 0 serious events
Other events: 1 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Alisporivir
n=5 participants at risk
Adverse event (AE) occurred while taking Alisporivir + PEGinf + RBV.
|
Boceprevir
n=8 participants at risk
AE occurred while taking Boceprevir + PEGinf + RBV.
|
PEGinf + RBV
n=8 participants at risk
AE occurred while taking only PEGinf + RBV.
|
No Intervention
n=6 participants at risk
AE was discovered while taking no intervention.
|
|---|---|---|---|---|
|
Respiratory, thoracic and mediastinal disorders
Chronic Obstructive Pulmonary Disease
|
0.00%
0/5
|
12.5%
1/8
|
0.00%
0/8
|
0.00%
0/6
|
Other adverse events
| Measure |
Alisporivir
n=5 participants at risk
Adverse event (AE) occurred while taking Alisporivir + PEGinf + RBV.
|
Boceprevir
n=8 participants at risk
AE occurred while taking Boceprevir + PEGinf + RBV.
|
PEGinf + RBV
n=8 participants at risk
AE occurred while taking only PEGinf + RBV.
|
No Intervention
n=6 participants at risk
AE was discovered while taking no intervention.
|
|---|---|---|---|---|
|
Skin and subcutaneous tissue disorders
Pruritus Generalised
|
20.0%
1/5
|
0.00%
0/8
|
0.00%
0/8
|
0.00%
0/6
|
|
Skin and subcutaneous tissue disorders
Rash Pruritic
|
40.0%
2/5
|
0.00%
0/8
|
0.00%
0/8
|
0.00%
0/6
|
|
Nervous system disorders
Headache
|
40.0%
2/5
|
25.0%
2/8
|
12.5%
1/8
|
0.00%
0/6
|
|
General disorders
Fatigue
|
20.0%
1/5
|
25.0%
2/8
|
37.5%
3/8
|
0.00%
0/6
|
|
Blood and lymphatic system disorders
Anaemia
|
0.00%
0/5
|
37.5%
3/8
|
0.00%
0/8
|
0.00%
0/6
|
|
General disorders
Influenza Like Illness
|
20.0%
1/5
|
0.00%
0/8
|
0.00%
0/8
|
0.00%
0/6
|
|
Metabolism and nutrition disorders
Decreased Appetite
|
20.0%
1/5
|
0.00%
0/8
|
12.5%
1/8
|
0.00%
0/6
|
|
Blood and lymphatic system disorders
Neutropenia
|
20.0%
1/5
|
12.5%
1/8
|
12.5%
1/8
|
0.00%
0/6
|
|
Metabolism and nutrition disorders
Hypertriglyceridaemia
|
20.0%
1/5
|
0.00%
0/8
|
0.00%
0/8
|
0.00%
0/6
|
|
Nervous system disorders
Disturbance in Attention
|
20.0%
1/5
|
0.00%
0/8
|
0.00%
0/8
|
0.00%
0/6
|
|
Nervous system disorders
Dysgeusia
|
0.00%
0/5
|
12.5%
1/8
|
12.5%
1/8
|
0.00%
0/6
|
|
Eye disorders
Vision Blurred
|
20.0%
1/5
|
0.00%
0/8
|
0.00%
0/8
|
0.00%
0/6
|
|
Gastrointestinal disorders
Diarrhoea
|
20.0%
1/5
|
25.0%
2/8
|
25.0%
2/8
|
0.00%
0/6
|
|
General disorders
Pyrexia
|
20.0%
1/5
|
0.00%
0/8
|
12.5%
1/8
|
0.00%
0/6
|
|
Investigations
Haematocrit Decreased
|
20.0%
1/5
|
12.5%
1/8
|
0.00%
0/8
|
0.00%
0/6
|
|
Investigations
Haemoglobin Decreased
|
20.0%
1/5
|
12.5%
1/8
|
0.00%
0/8
|
0.00%
0/6
|
|
General disorders
Chest Discomfort
|
0.00%
0/5
|
12.5%
1/8
|
0.00%
0/8
|
0.00%
0/6
|
|
Nervous system disorders
Dizziness
|
0.00%
0/5
|
12.5%
1/8
|
25.0%
2/8
|
0.00%
0/6
|
|
Infections and infestations
Nasopharyngitis
|
0.00%
0/5
|
12.5%
1/8
|
0.00%
0/8
|
0.00%
0/6
|
|
Gastrointestinal disorders
Gastric Ulcer
|
0.00%
0/5
|
0.00%
0/8
|
0.00%
0/8
|
16.7%
1/6
|
|
Gastrointestinal disorders
Vomiting
|
20.0%
1/5
|
0.00%
0/8
|
12.5%
1/8
|
0.00%
0/6
|
|
Infections and infestations
Gastroenteritis Viral
|
0.00%
0/5
|
12.5%
1/8
|
0.00%
0/8
|
0.00%
0/6
|
|
General disorders
Pain
|
20.0%
1/5
|
12.5%
1/8
|
12.5%
1/8
|
0.00%
0/6
|
|
Gastrointestinal disorders
Nausea
|
20.0%
1/5
|
12.5%
1/8
|
25.0%
2/8
|
0.00%
0/6
|
|
Psychiatric disorders
Sleep Disorder
|
0.00%
0/5
|
0.00%
0/8
|
25.0%
2/8
|
0.00%
0/6
|
|
Psychiatric disorders
Libido Decreased
|
0.00%
0/5
|
0.00%
0/8
|
25.0%
2/8
|
0.00%
0/6
|
|
Vascular disorders
Hot Flush
|
0.00%
0/5
|
0.00%
0/8
|
12.5%
1/8
|
0.00%
0/6
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
0.00%
0/5
|
0.00%
0/8
|
25.0%
2/8
|
0.00%
0/6
|
|
Gastrointestinal disorders
Dry Mouth
|
0.00%
0/5
|
0.00%
0/8
|
25.0%
2/8
|
0.00%
0/6
|
|
Infections and infestations
Pharyngitis Streptococcal
|
0.00%
0/5
|
12.5%
1/8
|
0.00%
0/8
|
0.00%
0/6
|
|
Immune system disorders
Seasonal Allergy
|
0.00%
0/5
|
0.00%
0/8
|
12.5%
1/8
|
0.00%
0/6
|
|
Nervous system disorders
Ageusia
|
0.00%
0/5
|
0.00%
0/8
|
12.5%
1/8
|
0.00%
0/6
|
|
Metabolism and nutrition disorders
Gout
|
0.00%
0/5
|
0.00%
0/8
|
12.5%
1/8
|
0.00%
0/6
|
|
Infections and infestations
Oral Candidiasis
|
0.00%
0/5
|
12.5%
1/8
|
0.00%
0/8
|
0.00%
0/6
|
|
Investigations
Blood Creatinine Increased
|
0.00%
0/5
|
0.00%
0/8
|
12.5%
1/8
|
0.00%
0/6
|
|
General disorders
Injection Site Erythema
|
0.00%
0/5
|
0.00%
0/8
|
12.5%
1/8
|
0.00%
0/6
|
|
Skin and subcutaneous tissue disorders
Rash
|
0.00%
0/5
|
12.5%
1/8
|
12.5%
1/8
|
0.00%
0/6
|
|
General disorders
Non-Cardiac Chest Pain
|
0.00%
0/5
|
0.00%
0/8
|
12.5%
1/8
|
0.00%
0/6
|
|
Psychiatric disorders
Confusional State
|
0.00%
0/5
|
0.00%
0/8
|
12.5%
1/8
|
0.00%
0/6
|
|
Nervous system disorders
Memory Impairment
|
0.00%
0/5
|
0.00%
0/8
|
12.5%
1/8
|
0.00%
0/6
|
|
Gastrointestinal disorders
Abdominal Pain Upper
|
0.00%
0/5
|
0.00%
0/8
|
12.5%
1/8
|
0.00%
0/6
|
|
General disorders
Irritability
|
0.00%
0/5
|
0.00%
0/8
|
12.5%
1/8
|
0.00%
0/6
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea
|
0.00%
0/5
|
0.00%
0/8
|
12.5%
1/8
|
0.00%
0/6
|
Additional Information
Vice President Clinical Research & Development
Debiopharm International S.A.
Phone: 4121 321 01 11
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place
Restriction type: OTHER