Trial Outcomes & Findings for Study to Evaluate the Safety and Efficacy of Daclatasvir/Sofosbuvir/Ribavirin for 16 Versus 24 Weeks for HCV Genotype 3 Cirrhotics (NCT NCT02304159)
NCT ID: NCT02304159
Last Updated: 2019-04-24
Results Overview
This field states the number of participants who had an adverse event
Recruitment status
COMPLETED
Study phase
PHASE4
Target enrollment
39 participants
Primary outcome timeframe
From baseline (start of study drugs) to last day of taking study drugs; an average of 20 weeks.
Results posted on
2019-04-24
Participant Flow
Participant milestones
| Measure |
Group A - 16 Weeks
Combination of sofosbuvir 400 mg daily, ribavirin 1000-1200 mg daily (weight based) and daclatasvir 60 mg daily for 16 weeks
daclatasvir, Daklinza
Sofosbuvir, Sovaldi
Ribavirin
|
Group B - 24 Weeks
Combination of sofosbuvir 400 mg daily, ribavirin 1000-1200 mg daily (weight based) and daclatasvir 60 mg daily for 24 weeks
daclatasvir, Daklinza
Sofosbuvir, Sovaldi
Ribavirin
|
|---|---|---|
|
Overall Study
STARTED
|
21
|
18
|
|
Overall Study
COMPLETED
|
19
|
16
|
|
Overall Study
NOT COMPLETED
|
2
|
2
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Study to Evaluate the Safety and Efficacy of Daclatasvir/Sofosbuvir/Ribavirin for 16 Versus 24 Weeks for HCV Genotype 3 Cirrhotics
Baseline characteristics by cohort
| Measure |
Group A - 16 Weeks
n=21 Participants
Combination of sofosbuvir 400 mg daily, ribavirin 1000-1200 mg daily (weight based) and daclatasvir 60 mg daily for 16 weeks
daclatasvir, Daklinza
Sofosbuvir, Sovaldi
Ribavirin
|
Group B - 24 Weeks
n=18 Participants
Combination of sofosbuvir 400 mg daily, ribavirin 1000-1200 mg daily (weight based) and daclatasvir 60 mg daily for 24 weeks
daclatasvir, Daklinza
Sofosbuvir, Sovaldi
Ribavirin
|
Total
n=39 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
54.62 years
STANDARD_DEVIATION 8.15 • n=5 Participants
|
55.72 years
STANDARD_DEVIATION 6.32 • n=7 Participants
|
55.13 years
STANDARD_DEVIATION 7.29 • n=5 Participants
|
|
Sex: Female, Male
Female
|
9 Participants
n=5 Participants
|
8 Participants
n=7 Participants
|
17 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
12 Participants
n=5 Participants
|
10 Participants
n=7 Participants
|
22 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
14 Participants
n=5 Participants
|
5 Participants
n=7 Participants
|
19 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
7 Participants
n=5 Participants
|
13 Participants
n=7 Participants
|
20 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
1 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Black or African American
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
19 Participants
n=5 Participants
|
18 Participants
n=7 Participants
|
37 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
1 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
|
Pre-treatment HCV RNA (viral load)
|
3009718.11 IU/mL
STANDARD_DEVIATION 3750275.88 • n=5 Participants
|
3165043.17 IU/mL
STANDARD_DEVIATION 4871398.73 • n=7 Participants
|
3085281.65 IU/mL
STANDARD_DEVIATION 4271365.19 • n=5 Participants
|
PRIMARY outcome
Timeframe: From baseline (start of study drugs) to last day of taking study drugs; an average of 20 weeks.This field states the number of participants who had an adverse event
Outcome measures
| Measure |
Group A - 16 Weeks
n=21 Participants
Combination of sofosbuvir 400 mg daily, ribavirin 1000-1200 mg daily (weight based) and daclatasvir 60 mg daily for 16 weeks
daclatasvir, Daklinza
Sofosbuvir, Sovaldi
Ribavirin
|
Group B - 24 Weeks
n=18 Participants
Combination of sofosbuvir 400 mg daily, ribavirin 1000-1200 mg daily (weight based) and daclatasvir 60 mg daily for 24 weeks
daclatasvir, Daklinza
Sofosbuvir, Sovaldi
Ribavirin
|
|---|---|---|
|
Number of Participants With Adverse Events
|
21 Participants
|
18 Participants
|
PRIMARY outcome
Timeframe: From baseline (start of study drugs) to last day of taking study drugs; an average of 20 weeks.This field states the number of participants who had an abnormal ALT that required discontinuing study drugs and/or abnormal Total Bilirubin that required discontinuing study drugs.
Outcome measures
| Measure |
Group A - 16 Weeks
n=21 Participants
Combination of sofosbuvir 400 mg daily, ribavirin 1000-1200 mg daily (weight based) and daclatasvir 60 mg daily for 16 weeks
daclatasvir, Daklinza
Sofosbuvir, Sovaldi
Ribavirin
|
Group B - 24 Weeks
n=18 Participants
Combination of sofosbuvir 400 mg daily, ribavirin 1000-1200 mg daily (weight based) and daclatasvir 60 mg daily for 24 weeks
daclatasvir, Daklinza
Sofosbuvir, Sovaldi
Ribavirin
|
|---|---|---|
|
Number of Participants With Abnormal Safety Laboratory Tests (ALT and/or Total Bilirubin) That Required Discontinuing Study Drugs
|
0 Participants
|
0 Participants
|
PRIMARY outcome
Timeframe: From baseline (start of study drugs) until 12 weeks after stopping study drugsPopulation: The analysis covers only the subjects who reached the 12 weeks after stopping study drugs time point. 19 of 21 participants randomized to Group A reached that timepoint and 16 of 18 participants randomized to Group B reached that timepoint.
Sustained Virologic Response (SVR) defined as undetectable HCV RNA 12 weeks after stopping study drugs.
Outcome measures
| Measure |
Group A - 16 Weeks
n=19 Participants
Combination of sofosbuvir 400 mg daily, ribavirin 1000-1200 mg daily (weight based) and daclatasvir 60 mg daily for 16 weeks
daclatasvir, Daklinza
Sofosbuvir, Sovaldi
Ribavirin
|
Group B - 24 Weeks
n=16 Participants
Combination of sofosbuvir 400 mg daily, ribavirin 1000-1200 mg daily (weight based) and daclatasvir 60 mg daily for 24 weeks
daclatasvir, Daklinza
Sofosbuvir, Sovaldi
Ribavirin
|
|---|---|---|
|
Number of Participants With Undetectable HCV Virus 12 Weeks After Stopping Study Drugs
|
19 Participants
|
16 Participants
|
Adverse Events
Group A - 16 Weeks of Treatment
Serious events: 0 serious events
Other events: 21 other events
Deaths: 1 deaths
Group A - 24 Weeks of Treatment
Serious events: 2 serious events
Other events: 18 other events
Deaths: 1 deaths
Serious adverse events
| Measure |
Group A - 16 Weeks of Treatment
n=21 participants at risk
Combination of sofosbuvir 400 mg daily, ribavirin 1000-1200 mg daily (weight based) and daclatasvir 60 mg daily for 16 weeks
daclatasvir, Daklinza
Sofosbuvir, Sovaldi
Ribavirin
|
Group A - 24 Weeks of Treatment
n=18 participants at risk
Combination of sofosbuvir 400 mg daily, ribavirin 1000-1200 mg daily (weight based) and daclatasvir 60 mg daily for 24 weeks
daclatasvir, Daklinza
Sofosbuvir, Sovaldi
Ribavirin
|
|---|---|---|
|
Infections and infestations
Infection
|
0.00%
0/21 • From start of treatment to 12 weeks after stopping treatment.
|
5.6%
1/18 • Number of events 1 • From start of treatment to 12 weeks after stopping treatment.
|
|
Social circumstances
Violence
|
0.00%
0/21 • From start of treatment to 12 weeks after stopping treatment.
|
5.6%
1/18 • Number of events 1 • From start of treatment to 12 weeks after stopping treatment.
|
Other adverse events
| Measure |
Group A - 16 Weeks of Treatment
n=21 participants at risk
Combination of sofosbuvir 400 mg daily, ribavirin 1000-1200 mg daily (weight based) and daclatasvir 60 mg daily for 16 weeks
daclatasvir, Daklinza
Sofosbuvir, Sovaldi
Ribavirin
|
Group A - 24 Weeks of Treatment
n=18 participants at risk
Combination of sofosbuvir 400 mg daily, ribavirin 1000-1200 mg daily (weight based) and daclatasvir 60 mg daily for 24 weeks
daclatasvir, Daklinza
Sofosbuvir, Sovaldi
Ribavirin
|
|---|---|---|
|
General disorders
Flu-like symptoms
|
47.6%
10/21 • Number of events 10 • From start of treatment to 12 weeks after stopping treatment.
|
50.0%
9/18 • Number of events 9 • From start of treatment to 12 weeks after stopping treatment.
|
|
Psychiatric disorders
Mood Changes
|
38.1%
8/21 • Number of events 8 • From start of treatment to 12 weeks after stopping treatment.
|
22.2%
4/18 • Number of events 4 • From start of treatment to 12 weeks after stopping treatment.
|
|
General disorders
Fatigue
|
23.8%
5/21 • Number of events 5 • From start of treatment to 12 weeks after stopping treatment.
|
33.3%
6/18 • Number of events 6 • From start of treatment to 12 weeks after stopping treatment.
|
|
Gastrointestinal disorders
Nausea
|
23.8%
5/21 • Number of events 5 • From start of treatment to 12 weeks after stopping treatment.
|
33.3%
6/18 • Number of events 6 • From start of treatment to 12 weeks after stopping treatment.
|
|
Gastrointestinal disorders
Abdominal Pain
|
23.8%
5/21 • Number of events 5 • From start of treatment to 12 weeks after stopping treatment.
|
22.2%
4/18 • Number of events 4 • From start of treatment to 12 weeks after stopping treatment.
|
|
Gastrointestinal disorders
Diarrhea
|
14.3%
3/21 • Number of events 3 • From start of treatment to 12 weeks after stopping treatment.
|
27.8%
5/18 • Number of events 5 • From start of treatment to 12 weeks after stopping treatment.
|
|
Psychiatric disorders
Insomnia
|
19.0%
4/21 • Number of events 4 • From start of treatment to 12 weeks after stopping treatment.
|
22.2%
4/18 • Number of events 4 • From start of treatment to 12 weeks after stopping treatment.
|
|
Hepatobiliary disorders
Decompensation
|
14.3%
3/21 • Number of events 3 • From start of treatment to 12 weeks after stopping treatment.
|
27.8%
5/18 • Number of events 5 • From start of treatment to 12 weeks after stopping treatment.
|
|
General disorders
Decreased Appetite
|
14.3%
3/21 • Number of events 3 • From start of treatment to 12 weeks after stopping treatment.
|
22.2%
4/18 • Number of events 4 • From start of treatment to 12 weeks after stopping treatment.
|
|
Skin and subcutaneous tissue disorders
Rash
|
14.3%
3/21 • Number of events 3 • From start of treatment to 12 weeks after stopping treatment.
|
16.7%
3/18 • Number of events 3 • From start of treatment to 12 weeks after stopping treatment.
|
|
Nervous system disorders
Headache
|
9.5%
2/21 • Number of events 2 • From start of treatment to 12 weeks after stopping treatment.
|
22.2%
4/18 • Number of events 4 • From start of treatment to 12 weeks after stopping treatment.
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnea
|
4.8%
1/21 • Number of events 1 • From start of treatment to 12 weeks after stopping treatment.
|
16.7%
3/18 • Number of events 3 • From start of treatment to 12 weeks after stopping treatment.
|
|
Nervous system disorders
Dizziness
|
9.5%
2/21 • Number of events 2 • From start of treatment to 12 weeks after stopping treatment.
|
11.1%
2/18 • Number of events 2 • From start of treatment to 12 weeks after stopping treatment.
|
|
Gastrointestinal disorders
Vomiting
|
9.5%
2/21 • Number of events 2 • From start of treatment to 12 weeks after stopping treatment.
|
11.1%
2/18 • Number of events 2 • From start of treatment to 12 weeks after stopping treatment.
|
|
Blood and lymphatic system disorders
Anemia
|
9.5%
2/21 • Number of events 2 • From start of treatment to 12 weeks after stopping treatment.
|
5.6%
1/18 • Number of events 1 • From start of treatment to 12 weeks after stopping treatment.
|
|
Skin and subcutaneous tissue disorders
Pruritus
|
0.00%
0/21 • From start of treatment to 12 weeks after stopping treatment.
|
11.1%
2/18 • Number of events 2 • From start of treatment to 12 weeks after stopping treatment.
|
|
Metabolism and nutrition disorders
Dehydration
|
0.00%
0/21 • From start of treatment to 12 weeks after stopping treatment.
|
11.1%
2/18 • Number of events 2 • From start of treatment to 12 weeks after stopping treatment.
|
Additional Information
Dr. Tarek Hassanein
Southern California Research Center
Phone: 619-319-3993
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place