Trial Outcomes & Findings for GS-7977 With Ribavirin for Hepatitis C (SPARE) (NCT NCT01441180)
NCT ID: NCT01441180
Last Updated: 2014-09-26
Results Overview
Number of participants with Grade 3-4 Adverse Events During the Study Treatment Period as a measure of safety and tolerability.
Recruitment status
COMPLETED
Study phase
PHASE1/PHASE2
Target enrollment
60 participants
Primary outcome timeframe
24 weeks
Results posted on
2014-09-26
Participant Flow
Participant milestones
| Measure |
Phase 1
(N =10): Participants will be enrolled and will receive GS-7977 QD in combination with RBV for a total of 24 weeks. The study team will perform an interim evaluation of data and safety at the end of 12 weeks of treatment.
|
Phase 2 Arm A
(N =25): 24 weeks of GS-7977 QD in combination with weight based RBV (1000 mg for participants weighing \<75 kg and 1200 mg for participants weighing ≥75kg)
|
Phase 2 Arm B
(N = 25): 24 weeks of GS-7977 QD with low dose RBV (600mg).
|
|---|---|---|---|
|
Overall Study
STARTED
|
10
|
25
|
25
|
|
Overall Study
COMPLETED
|
9
|
24
|
22
|
|
Overall Study
NOT COMPLETED
|
1
|
1
|
3
|
Reasons for withdrawal
| Measure |
Phase 1
(N =10): Participants will be enrolled and will receive GS-7977 QD in combination with RBV for a total of 24 weeks. The study team will perform an interim evaluation of data and safety at the end of 12 weeks of treatment.
|
Phase 2 Arm A
(N =25): 24 weeks of GS-7977 QD in combination with weight based RBV (1000 mg for participants weighing \<75 kg and 1200 mg for participants weighing ≥75kg)
|
Phase 2 Arm B
(N = 25): 24 weeks of GS-7977 QD with low dose RBV (600mg).
|
|---|---|---|---|
|
Overall Study
Lost to Follow-up
|
1
|
1
|
1
|
|
Overall Study
Discontinued
|
0
|
0
|
2
|
Baseline Characteristics
GS-7977 With Ribavirin for Hepatitis C (SPARE)
Baseline characteristics by cohort
| Measure |
Phase 1
n=10 Participants
(N =10): Participants will be enrolled and will receive GS-7977 QD in combination with RBV for a total of 24 weeks. The study team will perform an interim evaluation of data and safety at the end of 12 weeks of treatment.
|
Phase 2 Arm A
n=25 Participants
(N =25): 24 weeks of GS-7977 QD in combination with weight based RBV (1000 mg for participants weighing \<75 kg and 1200 mg for participants weighing ≥75kg)
|
Phase 2 Arm B
n=25 Participants
(N = 25): 24 weeks of GS-7977 QD with low dose RBV (600mg).
|
Total
n=60 Participants
Total of all reporting groups
|
|---|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
10 Participants
n=5 Participants
|
25 Participants
n=7 Participants
|
25 Participants
n=5 Participants
|
60 Participants
n=4 Participants
|
|
Age, Categorical
>=65 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
|
Sex: Female, Male
Female
|
6 Participants
n=5 Participants
|
6 Participants
n=7 Participants
|
11 Participants
n=5 Participants
|
23 Participants
n=4 Participants
|
|
Sex: Female, Male
Male
|
4 Participants
n=5 Participants
|
19 Participants
n=7 Participants
|
14 Participants
n=5 Participants
|
37 Participants
n=4 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
|
Race (NIH/OMB)
Black or African American
|
9 Participants
n=5 Participants
|
18 Participants
n=7 Participants
|
23 Participants
n=5 Participants
|
50 Participants
n=4 Participants
|
|
Race (NIH/OMB)
White
|
1 Participants
n=5 Participants
|
6 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
9 Participants
n=4 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
1 Participants
n=4 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
0 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
2 Participants
n=4 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
10 Participants
n=5 Participants
|
23 Participants
n=7 Participants
|
25 Participants
n=5 Participants
|
58 Participants
n=4 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
|
Region of Enrollment
United States
|
10 participants
n=5 Participants
|
25 participants
n=7 Participants
|
25 participants
n=5 Participants
|
60 participants
n=4 Participants
|
PRIMARY outcome
Timeframe: 24 weeksNumber of participants with Grade 3-4 Adverse Events During the Study Treatment Period as a measure of safety and tolerability.
Outcome measures
| Measure |
Phase 1
n=10 Participants
|
Phase 2 Arm A (Sofosbuvir + Weight Based RBV)
n=25 Participants
(N =25): 24 weeks of GS-7977 QD in combination with weight based RBV (1000 mg for participants weighing \<75 kg and 1200 mg for participants weighing ≥75kg)
|
Phase 2 Arm B (Sofosbuvir + Low-dose RBV)
n=25 Participants
(N = 25): 24 weeks of GS-7977 QD with low dose RBV (600mg).
|
|---|---|---|---|
|
Participants With Adverse Events
Any grade 3-4 event
|
1 partipants
|
1 partipants
|
5 partipants
|
|
Participants With Adverse Events
Any Serious Adverse Event
|
0 partipants
|
0 partipants
|
1 partipants
|
|
Participants With Adverse Events
Death
|
0 partipants
|
0 partipants
|
0 partipants
|
|
Participants With Adverse Events
Discontinuation owing to an adverse event
|
0 partipants
|
0 partipants
|
0 partipants
|
PRIMARY outcome
Timeframe: 24 weeks post treatment completionPopulation: on protocol analysis
Sustained virology response at 24 weeks post treatment completion
Outcome measures
| Measure |
Phase 1
n=10 Participants
|
Phase 2 Arm A (Sofosbuvir + Weight Based RBV)
n=25 Participants
(N =25): 24 weeks of GS-7977 QD in combination with weight based RBV (1000 mg for participants weighing \<75 kg and 1200 mg for participants weighing ≥75kg)
|
Phase 2 Arm B (Sofosbuvir + Low-dose RBV)
n=25 Participants
(N = 25): 24 weeks of GS-7977 QD with low dose RBV (600mg).
|
|---|---|---|---|
|
Sustained Virologic Response
|
100 percentage of total participants
Interval 66.0 to 100.0
|
71 percentage of total participants
Interval 49.0 to 87.0
|
55 percentage of total participants
Interval 32.0 to 76.0
|
Adverse Events
Phase 1 (Sofosbuvir + Weight Based RBV)
Serious events: 0 serious events
Other events: 9 other events
Deaths: 0 deaths
Phase 2 Arm A (Sofosbuvir + Weight Based RBV)
Serious events: 0 serious events
Other events: 24 other events
Deaths: 0 deaths
Phase 2 Arm B (Sofosbuvir + Low-dose RBV)
Serious events: 2 serious events
Other events: 21 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Phase 1 (Sofosbuvir + Weight Based RBV)
n=10 participants at risk
(N =10): 24 weeks of GS-7977 QD in combination with weight based RBV (1000 mg for participants weighing \<75 kg and 1200 mg for participants weighing ≥75kg)
|
Phase 2 Arm A (Sofosbuvir + Weight Based RBV)
n=25 participants at risk
(N =25): 24 weeks of GS-7977 QD in combination with weight based RBV (1000 mg for participants weighing \<75 kg and 1200 mg for participants weighing ≥75kg)
|
Phase 2 Arm B (Sofosbuvir + Low-dose RBV)
n=25 participants at risk
(N = 25): 24 weeks of GS-7977 QD with low dose RBV (600mg).
|
|---|---|---|---|
|
Gastrointestinal disorders
Pancreatitis
|
0.00%
0/10 • Entire treatment period through 12 weeks post treatment completion
|
0.00%
0/25 • Entire treatment period through 12 weeks post treatment completion
|
4.0%
1/25 • Number of events 1 • Entire treatment period through 12 weeks post treatment completion
|
|
Hepatobiliary disorders
Cholelithiasis
|
0.00%
0/10 • Entire treatment period through 12 weeks post treatment completion
|
0.00%
0/25 • Entire treatment period through 12 weeks post treatment completion
|
4.0%
1/25 • Number of events 1 • Entire treatment period through 12 weeks post treatment completion
|
Other adverse events
| Measure |
Phase 1 (Sofosbuvir + Weight Based RBV)
n=10 participants at risk
(N =10): 24 weeks of GS-7977 QD in combination with weight based RBV (1000 mg for participants weighing \<75 kg and 1200 mg for participants weighing ≥75kg)
|
Phase 2 Arm A (Sofosbuvir + Weight Based RBV)
n=25 participants at risk
(N =25): 24 weeks of GS-7977 QD in combination with weight based RBV (1000 mg for participants weighing \<75 kg and 1200 mg for participants weighing ≥75kg)
|
Phase 2 Arm B (Sofosbuvir + Low-dose RBV)
n=25 participants at risk
(N = 25): 24 weeks of GS-7977 QD with low dose RBV (600mg).
|
|---|---|---|---|
|
Investigations
Blood glucose increased
|
0.00%
0/10 • Entire treatment period through 12 weeks post treatment completion
|
4.0%
1/25 • Number of events 2 • Entire treatment period through 12 weeks post treatment completion
|
8.0%
2/25 • Number of events 2 • Entire treatment period through 12 weeks post treatment completion
|
|
Investigations
Creatinine increased
|
0.00%
0/10 • Entire treatment period through 12 weeks post treatment completion
|
8.0%
2/25 • Number of events 3 • Entire treatment period through 12 weeks post treatment completion
|
12.0%
3/25 • Number of events 7 • Entire treatment period through 12 weeks post treatment completion
|
|
Nervous system disorders
Dizziness
|
0.00%
0/10 • Entire treatment period through 12 weeks post treatment completion
|
8.0%
2/25 • Number of events 2 • Entire treatment period through 12 weeks post treatment completion
|
4.0%
1/25 • Number of events 1 • Entire treatment period through 12 weeks post treatment completion
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnea
|
10.0%
1/10 • Number of events 1 • Entire treatment period through 12 weeks post treatment completion
|
8.0%
2/25 • Number of events 2 • Entire treatment period through 12 weeks post treatment completion
|
8.0%
2/25 • Number of events 2 • Entire treatment period through 12 weeks post treatment completion
|
|
General disorders
Fatigue
|
30.0%
3/10 • Number of events 4 • Entire treatment period through 12 weeks post treatment completion
|
16.0%
4/25 • Number of events 5 • Entire treatment period through 12 weeks post treatment completion
|
24.0%
6/25 • Number of events 6 • Entire treatment period through 12 weeks post treatment completion
|
|
Nervous system disorders
Headache
|
20.0%
2/10 • Number of events 3 • Entire treatment period through 12 weeks post treatment completion
|
28.0%
7/25 • Number of events 10 • Entire treatment period through 12 weeks post treatment completion
|
28.0%
7/25 • Number of events 8 • Entire treatment period through 12 weeks post treatment completion
|
|
Investigations
Hemoglobin decreased
|
40.0%
4/10 • Number of events 7 • Entire treatment period through 12 weeks post treatment completion
|
32.0%
8/25 • Number of events 16 • Entire treatment period through 12 weeks post treatment completion
|
16.0%
4/25 • Number of events 9 • Entire treatment period through 12 weeks post treatment completion
|
|
Hepatobiliary disorders
Hyperbiliurbinemia
|
20.0%
2/10 • Number of events 5 • Entire treatment period through 12 weeks post treatment completion
|
32.0%
8/25 • Number of events 24 • Entire treatment period through 12 weeks post treatment completion
|
12.0%
3/25 • Number of events 6 • Entire treatment period through 12 weeks post treatment completion
|
|
Gastrointestinal disorders
Nausea
|
10.0%
1/10 • Number of events 1 • Entire treatment period through 12 weeks post treatment completion
|
16.0%
4/25 • Number of events 4 • Entire treatment period through 12 weeks post treatment completion
|
20.0%
5/25 • Number of events 7 • Entire treatment period through 12 weeks post treatment completion
|
|
Skin and subcutaneous tissue disorders
Pruritic rash
|
10.0%
1/10 • Number of events 1 • Entire treatment period through 12 weeks post treatment completion
|
12.0%
3/25 • Number of events 3 • Entire treatment period through 12 weeks post treatment completion
|
0.00%
0/25 • Entire treatment period through 12 weeks post treatment completion
|
|
Investigations
Serum calcium decreased
|
10.0%
1/10 • Number of events 1 • Entire treatment period through 12 weeks post treatment completion
|
24.0%
6/25 • Number of events 6 • Entire treatment period through 12 weeks post treatment completion
|
20.0%
5/25 • Number of events 7 • Entire treatment period through 12 weeks post treatment completion
|
|
Investigations
Serum phosphate decreased
|
0.00%
0/10 • Entire treatment period through 12 weeks post treatment completion
|
24.0%
6/25 • Number of events 9 • Entire treatment period through 12 weeks post treatment completion
|
32.0%
8/25 • Number of events 12 • Entire treatment period through 12 weeks post treatment completion
|
|
Gastrointestinal disorders
Vomiting
|
0.00%
0/10 • Entire treatment period through 12 weeks post treatment completion
|
0.00%
0/25 • Entire treatment period through 12 weeks post treatment completion
|
12.0%
3/25 • Number of events 3 • Entire treatment period through 12 weeks post treatment completion
|
|
Musculoskeletal and connective tissue disorders
Myalgia
|
0.00%
0/10 • Entire treatment period through 12 weeks post treatment completion
|
0.00%
0/25 • Entire treatment period through 12 weeks post treatment completion
|
8.0%
2/25 • Number of events 2 • Entire treatment period through 12 weeks post treatment completion
|
|
Nervous system disorders
Light headedness
|
0.00%
0/10 • Entire treatment period through 12 weeks post treatment completion
|
4.0%
1/25 • Number of events 1 • Entire treatment period through 12 weeks post treatment completion
|
8.0%
2/25 • Number of events 2 • Entire treatment period through 12 weeks post treatment completion
|
|
Investigations
Blood phosphorus decreased
|
20.0%
2/10 • Number of events 7 • Entire treatment period through 12 weeks post treatment completion
|
0.00%
0/25 • Entire treatment period through 12 weeks post treatment completion
|
0.00%
0/25 • Entire treatment period through 12 weeks post treatment completion
|
|
Investigations
Blood magnesium decreased
|
20.0%
2/10 • Number of events 4 • Entire treatment period through 12 weeks post treatment completion
|
0.00%
0/25 • Entire treatment period through 12 weeks post treatment completion
|
0.00%
0/25 • Entire treatment period through 12 weeks post treatment completion
|
|
Investigations
Blood sodium decreased
|
20.0%
2/10 • Number of events 2 • Entire treatment period through 12 weeks post treatment completion
|
0.00%
0/25 • Entire treatment period through 12 weeks post treatment completion
|
0.00%
0/25 • Entire treatment period through 12 weeks post treatment completion
|
|
Metabolism and nutrition disorders
Decreased appetite
|
10.0%
1/10 • Number of events 1 • Entire treatment period through 12 weeks post treatment completion
|
0.00%
0/25 • Entire treatment period through 12 weeks post treatment completion
|
0.00%
0/25 • Entire treatment period through 12 weeks post treatment completion
|
|
Skin and subcutaneous tissue disorders
Rash
|
10.0%
1/10 • Number of events 1 • Entire treatment period through 12 weeks post treatment completion
|
0.00%
0/25 • Entire treatment period through 12 weeks post treatment completion
|
0.00%
0/25 • Entire treatment period through 12 weeks post treatment completion
|
|
Skin and subcutaneous tissue disorders
Skin Ulcer
|
10.0%
1/10 • Number of events 1 • Entire treatment period through 12 weeks post treatment completion
|
0.00%
0/25 • Entire treatment period through 12 weeks post treatment completion
|
0.00%
0/25 • Entire treatment period through 12 weeks post treatment completion
|
|
Gastrointestinal disorders
Abdominal Pain
|
10.0%
1/10 • Number of events 1 • Entire treatment period through 12 weeks post treatment completion
|
0.00%
0/25 • Entire treatment period through 12 weeks post treatment completion
|
0.00%
0/25 • Entire treatment period through 12 weeks post treatment completion
|
|
Gastrointestinal disorders
Lip swelling
|
10.0%
1/10 • Number of events 2 • Entire treatment period through 12 weeks post treatment completion
|
0.00%
0/25 • Entire treatment period through 12 weeks post treatment completion
|
0.00%
0/25 • Entire treatment period through 12 weeks post treatment completion
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place