Trial Outcomes & Findings for Study of CDI-31244 in Combination With Sofosbuvir (SOF) and Velpatasvir (VEL) (NCT NCT03501550)
NCT ID: NCT03501550
Last Updated: 2021-04-28
Results Overview
The safety and the tolerability of CDI-31244 in combination with SOF/VEL through number of AEs observed in participants
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
12 participants
Primary outcome timeframe
Day 1 to Day 72
Results posted on
2021-04-28
Participant Flow
Participant milestones
| Measure |
CDI-31244 + SOF/VEL
2 wks of CDI-31244 in combination with 6 wks of SOF/VEL
CDI-31244: investigational drug
SOF/VEL: sofosbuvir and velpatasvir fixed dose combination
|
|---|---|
|
Overall Study
STARTED
|
12
|
|
Overall Study
COMPLETED
|
12
|
|
Overall Study
NOT COMPLETED
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Study of CDI-31244 in Combination With Sofosbuvir (SOF) and Velpatasvir (VEL)
Baseline characteristics by cohort
| Measure |
Subjects
n=12 Participants
number of subjects in the study
|
|---|---|
|
Age, Continuous
|
44.08 years
STANDARD_DEVIATION 11.02 • n=5 Participants
|
|
Sex: Female, Male
Female
|
6 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
6 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
3 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
9 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
1 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Black or African American
|
7 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
3 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
1 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
12 Participants
n=5 Participants
|
|
HCV load
|
6.59 log10 IU/mL
STANDARD_DEVIATION 0.62 • n=5 Participants
|
PRIMARY outcome
Timeframe: Day 1 to Day 72The safety and the tolerability of CDI-31244 in combination with SOF/VEL through number of AEs observed in participants
Outcome measures
| Measure |
CDI-31244 + SOF/VEL
n=12 Participants
2 wks of CDI-31244 in combination with 6 wks of SOF/VEL
CDI-31244: investigational drug
SOF/VEL: sofosbuvir and velpatasvir fixed dose combination
|
|---|---|
|
Number of Subjects With Treatment Emergent Adverse Events
|
10 Participants
|
PRIMARY outcome
Timeframe: post-treatment Week 12SVR12 is defined as HCV RNA \< the lower limit of quantitation (LLOQ) at 12 weeks after treatment
Outcome measures
| Measure |
CDI-31244 + SOF/VEL
n=12 Participants
2 wks of CDI-31244 in combination with 6 wks of SOF/VEL
CDI-31244: investigational drug
SOF/VEL: sofosbuvir and velpatasvir fixed dose combination
|
|---|---|
|
Number of Participants With Sustained Virologic Response (SVR) 12 Weeks After Treatment
|
8 Participants
|
SECONDARY outcome
Timeframe: post-treatment Week 24SVR (sustained virologic response) 24 is defined as HCV RNA \< the lower limit of quantitation (LLOQ) at 24 weeks after treatment
Outcome measures
| Measure |
CDI-31244 + SOF/VEL
n=12 Participants
2 wks of CDI-31244 in combination with 6 wks of SOF/VEL
CDI-31244: investigational drug
SOF/VEL: sofosbuvir and velpatasvir fixed dose combination
|
|---|---|
|
Number of Participants With Sustained Virologic Response (SVR) 24 Weeks After Discontinuation of Therapy
|
8 Participants
|
Adverse Events
CDI-31244 + SOF/VEL
Serious events: 1 serious events
Other events: 10 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
CDI-31244 + SOF/VEL
n=12 participants at risk；n=6 participants at risk
2 wks of CDI-31244 in combination with 6 wks of SOF/VEL
CDI-31244: investigational drug
SOF/VEL: sofosbuvir and velpatasvir fixed dose combination
|
|---|---|
|
Pregnancy, puerperium and perinatal conditions
Abortion spontaneous
|
16.7%
1/6 • Number of events 1 • from signing of informed consent to fours weeks after end of treatment (from Study Day 1 to Study Day 72)
|
Other adverse events
| Measure |
CDI-31244 + SOF/VEL
n=12 participants at risk；n=6 participants at risk
2 wks of CDI-31244 in combination with 6 wks of SOF/VEL
CDI-31244: investigational drug
SOF/VEL: sofosbuvir and velpatasvir fixed dose combination
|
|---|---|
|
Nervous system disorders
Headache
|
41.7%
5/12 • Number of events 9 • from signing of informed consent to fours weeks after end of treatment (from Study Day 1 to Study Day 72)
|
|
Gastrointestinal disorders
Nausea
|
25.0%
3/12 • Number of events 3 • from signing of informed consent to fours weeks after end of treatment (from Study Day 1 to Study Day 72)
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
16.7%
2/12 • Number of events 2 • from signing of informed consent to fours weeks after end of treatment (from Study Day 1 to Study Day 72)
|
|
Gastrointestinal disorders
Diarrhea
|
16.7%
2/12 • Number of events 2 • from signing of informed consent to fours weeks after end of treatment (from Study Day 1 to Study Day 72)
|
|
Infections and infestations
Nasopharyngitis
|
16.7%
2/12 • Number of events 2 • from signing of informed consent to fours weeks after end of treatment (from Study Day 1 to Study Day 72)
|
|
Gastrointestinal disorders
Abdominal distention
|
8.3%
1/12 • Number of events 1 • from signing of informed consent to fours weeks after end of treatment (from Study Day 1 to Study Day 72)
|
|
Surgical and medical procedures
Bunion operation
|
8.3%
1/12 • Number of events 1 • from signing of informed consent to fours weeks after end of treatment (from Study Day 1 to Study Day 72)
|
|
Injury, poisoning and procedural complications
Contusion
|
8.3%
1/12 • Number of events 1 • from signing of informed consent to fours weeks after end of treatment (from Study Day 1 to Study Day 72)
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
8.3%
1/12 • Number of events 1 • from signing of informed consent to fours weeks after end of treatment (from Study Day 1 to Study Day 72)
|
|
Nervous system disorders
Dizziness
|
8.3%
1/12 • Number of events 1 • from signing of informed consent to fours weeks after end of treatment (from Study Day 1 to Study Day 72)
|
|
General disorders
Fatigue
|
8.3%
1/12 • Number of events 1 • from signing of informed consent to fours weeks after end of treatment (from Study Day 1 to Study Day 72)
|
|
Injury, poisoning and procedural complications
Joint Injury
|
8.3%
1/12 • Number of events 1 • from signing of informed consent to fours weeks after end of treatment (from Study Day 1 to Study Day 72)
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal pain
|
8.3%
1/12 • Number of events 1 • from signing of informed consent to fours weeks after end of treatment (from Study Day 1 to Study Day 72)
|
|
Musculoskeletal and connective tissue disorders
Myalgia
|
8.3%
1/12 • Number of events 1 • from signing of informed consent to fours weeks after end of treatment (from Study Day 1 to Study Day 72)
|
|
Musculoskeletal and connective tissue disorders
Pain in extremity
|
8.3%
1/12 • Number of events 1 • from signing of informed consent to fours weeks after end of treatment (from Study Day 1 to Study Day 72)
|
|
Musculoskeletal and connective tissue disorders
Peripheral swelling
|
8.3%
1/12 • Number of events 1 • from signing of informed consent to fours weeks after end of treatment (from Study Day 1 to Study Day 72)
|
|
Musculoskeletal and connective tissue disorders
Plantar fasciitis
|
8.3%
1/12 • Number of events 1 • from signing of informed consent to fours weeks after end of treatment (from Study Day 1 to Study Day 72)
|
|
Skin and subcutaneous tissue disorders
Pruritus
|
8.3%
1/12 • Number of events 1 • from signing of informed consent to fours weeks after end of treatment (from Study Day 1 to Study Day 72)
|
|
Skin and subcutaneous tissue disorders
Rash pruritic
|
8.3%
1/12 • Number of events 1 • from signing of informed consent to fours weeks after end of treatment (from Study Day 1 to Study Day 72)
|
|
Respiratory, thoracic and mediastinal disorders
Sinus congestion
|
8.3%
1/12 • Number of events 1 • from signing of informed consent to fours weeks after end of treatment (from Study Day 1 to Study Day 72)
|
|
Nervous system disorders
Syncope
|
8.3%
1/12 • Number of events 1 • from signing of informed consent to fours weeks after end of treatment (from Study Day 1 to Study Day 72)
|
|
Gastrointestinal disorders
Toothache
|
8.3%
1/12 • Number of events 1 • from signing of informed consent to fours weeks after end of treatment (from Study Day 1 to Study Day 72)
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place
Restriction type: LTE60