Study of CDI-31244 in Combination With Sofosbuvir (SOF) and Velpatasvir (VEL)

• Sponsor: Cocrystal Pharma, Inc. (Industry)
• Overall Status: Completed
• CT.gov ID: NCT03501550
• Collaborator: (none)
• Enrollment: 12
• Location: 1
• Arm: 1
• Actual Duration (Months): 11.4
• Patients Per Site Per Month: 1.1

Study Details

Study Description

Brief Summary

Open label phase 2a study of two week treatment with CDI-31244 and sofosbuvir and veltapasvir followed by four week treatment of sofosbuvir and velpatasvir in individuals with chronic hepatitis C (HCV) genotype 1 (GT1) infection

Condition or Disease	Intervention/Treatment	Phase
Chronic Hepatitis C	Drug: CDI-31244; Drug: SOF/VEL	Phase 2

Detailed Description

The study is open label and has one treatment group. Eligible HCV GT1 subjects will self administer orally 400 mg of CDI-31244 and fixed dose combination of sofosbuvir and velpatasvir for 14 days. After 14 days the subjects will continue the treatment for another 4 weeks on the fixed dose combination sofosbuvir and velpatasvir. The subjects will be followed up until 24 weeks after the last dose of sofosbuvir and velpatasvir to determine if sustained virologic response at 12 (SVR12) and 24 (SVR24) weeks after treatment have been achieved.

Study Design

• Study Type: Interventional
• Actual Enrollment: 12 participants
• Allocation: N/A
• Intervention Model: Single Group Assignment
• Masking: None (Open Label)
• Primary Purpose: Treatment
• Official Title: An Open-Label Phase 2a Study Evaluating the Safety and Efficacy of Combination Treatment With 2 Weeks of the Non-Nucleoside Inhibitor CDI 31244 Plus 6 Weeks of Sofosbuvir/Velpatasvir in Subjects With Chronic Hepatitis C Genotype 1 Infection
• Actual Study Start Date: Jun 26, 2018
• Actual Primary Completion Date: Jan 8, 2019
• Actual Study Completion Date: Jun 7, 2019

Arms and Interventions

Arm	Intervention/Treatment
Experimental: CDI-31244 + SOF/VEL CDI-31244 in combination with SOF/VEL	Drug: CDI-31244; investigational drug; Other Names: CDI-31244 (non-nucleoside inhibitor or NNI) ; Drug: SOF/VEL; sofosbuvir and velpatasvir fixed dose combination; Other Names: Epclusa

Outcome Measures

Primary Outcome Measures

1. Number of Subjects With Treatment Emergent Adverse Events [Day 1 to Day 72]

   The safety and the tolerability of CDI-31244 in combination with SOF/VEL through number of AEs observed in participants

2. Number of Participants With Sustained Virologic Response (SVR) 12 Weeks After Treatment [post-treatment Week 12]

   SVR12 is defined as HCV RNA < the lower limit of quantitation (LLOQ) at 12 weeks after treatment

Secondary Outcome Measures

1. Number of Participants With Sustained Virologic Response (SVR) 24 Weeks After Discontinuation of Therapy [post-treatment Week 24]

   SVR (sustained virologic response) 24 is defined as HCV RNA < the lower limit of quantitation (LLOQ) at 24 weeks after treatment

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

Key Inclusion Criteria:

Documented chronic HCV GT 1 infection; Serum HCV RNA >1,000 IU/mL during screening; Absence of advanced fibrosis or cirrhosis

Key Exclusion Criteria:

Nursing or pregnant women; Active hepatitis B infection; Human immunodeficiency virus (HIV) infection; History of use of any HCV direct-acting antiviral therapy

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Institute of Human Virology University of Maryland	Baltimore	Maryland	United States	21201

Sponsors and Collaborators

• Cocrystal Pharma, Inc.

Investigators

• Principal Investigator: Joel Chua, MD, Institute of Human Virology, University of Maryland, Baltimore

Study Documents (Full-Text)

• Study Protocol - May 22, 2018
• Statistical Analysis Plan - Jan 7, 2019

More Information

Publications

None provided.

• Responsible Party: Cocrystal Pharma, Inc.
• ClinicalTrials.gov Identifier: NCT03501550
• Other Study ID Numbers: CDI-31244-P2-001
• First Posted: Apr 18, 2018
• Last Update Posted: Apr 28, 2021
• Last Verified: Apr 1, 2021

• Individual Participant Data (IPD) Sharing Statement: No
• Plan to Share IPD: No
• Studies a U.S. FDA-regulated Drug Product: Yes
• Studies a U.S. FDA-regulated Device Product: No
• Keywords provided by Cocrystal Pharma, Inc.: HCV; GT1
• Additional relevant MeSH terms: Hepatitis C; Hepatitis C, Chronic; Hepatitis; Hepatitis, Chronic; Sofosbuvir-velpatasvir drug combination

Study Results

Participant Flow

Arm/Group Title	CDI-31244 + SOF/VEL
Arm/Group Description	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
Period Title: Overall Study
STARTED	12
COMPLETED	12
NOT COMPLETED	0

Baseline Characteristics

Arm/Group Title	Subjects
Arm/Group Description	number of subjects in the study
Overall Participants	12
Age (years) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [years]	44.08 (11.02)
Sex: Female, Male (Count of Participants)
Female	6 50%
Male	6 50%
Ethnicity (NIH/OMB) (Count of Participants)
Hispanic or Latino	3 25%
Not Hispanic or Latino	9 75%
Unknown or Not Reported	0 0%
Race (NIH/OMB) (Count of Participants)
American Indian or Alaska Native	0 0%
Asian	1 8.3%
Native Hawaiian or Other Pacific Islander	0 0%
Black or African American	7 58.3%
White	3 25%
More than one race	0 0%
Unknown or Not Reported	1 8.3%
Region of Enrollment (Count of Participants)
United States	12 100%
HCV load (log10 IU/mL) [Median (Standard Deviation) ]
Median (Standard Deviation) [log10 IU/mL]	6.59 (0.62)

Outcome Measures

1. Primary Outcome

Title	Number of Subjects With Treatment Emergent Adverse Events
Description	The safety and the tolerability of CDI-31244 in combination with SOF/VEL through number of AEs observed in participants
Time Frame	Day 1 to Day 72

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	CDI-31244 + SOF/VEL
Arm/Group Description	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
Measure Participants	12
Count of Participants [Participants]	10 83.3%

2. Primary Outcome

Title	Number of Participants With Sustained Virologic Response (SVR) 12 Weeks After Treatment
Description	SVR12 is defined as HCV RNA < the lower limit of quantitation (LLOQ) at 12 weeks after treatment
Time Frame	post-treatment Week 12

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	CDI-31244 + SOF/VEL
Arm/Group Description	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
Measure Participants	12
Count of Participants [Participants]	8 66.7%

3. Secondary Outcome

Title	Number of Participants With Sustained Virologic Response (SVR) 24 Weeks After Discontinuation of Therapy
Description	SVR (sustained virologic response) 24 is defined as HCV RNA < the lower limit of quantitation (LLOQ) at 24 weeks after treatment
Time Frame	post-treatment Week 24

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	CDI-31244 + SOF/VEL
Arm/Group Description	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
Measure Participants	12
Count of Participants [Participants]	8 66.7%

Adverse Events

Time Frame	from signing of informed consent to fours weeks after end of treatment (from Study Day 1 to Study Day 72)
Arm/Group Title	CDI-31244 + SOF/VEL
Arm/Group Description	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
All Cause Mortality
	CDI-31244 + SOF/VEL
	Affected / at Risk (%)	# Events
Total	0/12 (0%)
Serious Adverse Events
	CDI-31244 + SOF/VEL
	Affected / at Risk (%)	# Events
Total	1/6 (16.7%)
Pregnancy, puerperium and perinatal conditions
Abortion spontaneous	1/6 (16.7%)	1
Other (Not Including Serious) Adverse Events
	CDI-31244 + SOF/VEL
	Affected / at Risk (%)	# Events
Total	10/12 (83.3%)
Gastrointestinal disorders
Nausea	3/12 (25%)	3
Diarrhea	2/12 (16.7%)	2
Abdominal distention	1/12 (8.3%)	1
Toothache	1/12 (8.3%)	1
General disorders
Fatigue	1/12 (8.3%)	1
Infections and infestations
Nasopharyngitis	2/12 (16.7%)	2
Injury, poisoning and procedural complications
Contusion	1/12 (8.3%)	1
Joint Injury	1/12 (8.3%)	1
Musculoskeletal and connective tissue disorders
Back pain	2/12 (16.7%)	2
Musculoskeletal pain	1/12 (8.3%)	1
Myalgia	1/12 (8.3%)	1
Pain in extremity	1/12 (8.3%)	1
Peripheral swelling	1/12 (8.3%)	1
Plantar fasciitis	1/12 (8.3%)	1
Nervous system disorders
Headache	5/12 (41.7%)	9
Dizziness	1/12 (8.3%)	1
Syncope	1/12 (8.3%)	1
Respiratory, thoracic and mediastinal disorders
Cough	1/12 (8.3%)	1
Sinus congestion	1/12 (8.3%)	1
Skin and subcutaneous tissue disorders
Pruritus	1/12 (8.3%)	1
Rash pruritic	1/12 (8.3%)	1
Surgical and medical procedures
Bunion operation	1/12 (8.3%)	1

Limitations/Caveats

[Not Specified]

More Information

Certain Agreements

Principal Investigators are NOT employed by the organization sponsoring the study.

The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is less than or equal to 60 days. The sponsor cannot require changes to the communication and cannot extend the embargo.