Chronic Hepatitis CPhase 2NCT03501550

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

A Phase 2 study testing CDI-31244 and SOF/VEL in people with Chronic Hepatitis C, run by Cocrystal Pharma, Inc. at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial 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 Read more about this study

Who is it for?: Ages 18 years and older
Conditions the study is for: Chronic Hepatitis C
What is being tested?: CDI-31244 and SOF/VEL
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 12 participants
Where: 1 siteUnited States
Study dates: 26 Jun 2018to 7 Jun 2019
Phase: Phase 2
Are there results?: Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 18 years and older
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

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

Who cannot join

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

Trial locations and contacts

1 site in 1 country.

United States1 site

Institute of Human Virology University of Maryland
Baltimore, Maryland, 21201

Other trials in United States

About this study

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

Read the 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.

Conditions: Chronic Hepatitis C
Being tested: CDI-31244, SOF/VEL
Keywords: HCV, GT1
Medical subject headings: Hepatitis C, Chronic

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

CDI-31244Drug
Also called CDI-31244 (non-nucleoside inhibitor or NNI)
investigational drug
SOF/VELDrug
Also called Epclusa
sofosbuvir and velpatasvir fixed dose combination

Study groups in NCT03501550
Study group	Role	What they receive
CDI-31244 + SOF/VEL	Experimental	CDI-31244 in combination with SOF/VEL Receives: Drug: CDI-31244; Drug: SOF/VEL

What is being measured

The primary outcome is the main question the study is designed to answer.

Number of Subjects With Treatment Emergent Adverse Events
The safety and the tolerability of CDI-31244 in combination with SOF/VEL through number of AEs observed in participants
Measured: Day 1 to Day 72
Number of Participants With Sustained Virologic Response (SVR) 12 Weeks After Treatment
SVR12 is defined as HCV RNA < the lower limit of quantitation (LLOQ) at 12 weeks after treatment
Measured: post-treatment Week 12

Secondary outcomes (1)

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

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

26 Jun 20187 Jun 2019

First posted18 Apr 2018
Study start26 Jun 2018
Primary completion8 Jan 2019
Study completion7 Jun 2019

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Other trials for Chronic Hepatitis CStudies of the same condition, open and under way.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase 2
Primary purpose: Treatment
Allocation: Not applicable
Intervention model: Single group
Masking: None (open label)
Enrolment: 12 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT03501550
Sponsor's protocol ID: CDI-31244-P2-001
Status last verified: Apr 2021
First submitted: 9 Apr 2018
Last updated: 28 Apr 2021
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No
FDA-regulated drug: Yes
FDA-regulated device: No
Individual data sharing: No

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

RecruitingObservational study
Evaluation of Patients With Liver Disease
Hepatitis D, Hepatitis C
RecruitingObservational study
"Constitution of a Biological Collection to Establish Preclinical Translational Models for the Study of Tumors and Chronic Liver Diseases".
Chronic Liver Disease and Cirrhosis, Liver Cancer
Active, not recruitingPhase 4
People With CHC Who Achieved a Sustained Virological Response Following Therapy With Direct Acting Antiviral Agents
Diabetes Mellitus, Hepatitis C, Chronic
Active, not recruitingPhase 4
Sofosbuvir/Velpatasvir Treatment of Chronic Hepatitis C During Pregnancy
Hepatitis C, Chronic, Pregnancy; Infection
Enrolling by invitationObservational study
Comparative Autoantibody and Immunologic Cell Marker Study
Autoimmune Diseases, Lupus Erythematosus, Systemic

All Chronic Hepatitis C trials

Study at a glance

From the registry record, last updated by the sponsor on 28 Apr 2021. Recruitment status is as the sponsor reported it: confirm with the study team.

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
ClinicalTrials.gov ID: NCT03501550
Acronym / sponsor ID: CDI-31244-P2-001
Conditions: Chronic Hepatitis C
Keywords: HCV, GT1
Phase: Phase 2
Study type: Interventional
Recruitment status: Completed
Enrolment: 12 participants (actual)
Lead sponsor: Cocrystal Pharma, Inc.Industry (pharma, biotech, devices)
Study start: 26 Jun 2018 (actual)
Primary completion: 8 Jan 2019 (actual)
Study completion: 7 Jun 2019 (actual)
First posted: 18 Apr 2018 (actual)
Results: Posted 28 Apr 2021

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Detailed description

Study design

Primary purpose: Treatment
Allocation: Not applicable
Intervention model: Single group
Masking: None (open label)
Number of arms: 1

Arm	Type	Receives
CDI-31244 + SOF/VEL	Experimental	Drug: CDI-31244, Drug: SOF/VELCDI-31244 in combination with SOF/VEL

Who may qualify

Ages: 18 years and older
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (1 listed)

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

Key exclusion criteria (1 listed)

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

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
CDI-31244Also: CDI-31244 (non-nucleoside inhibitor or NNI)investigational drug	Drug	CDI-31244 + SOF/VEL
SOF/VELAlso: Epclusasofosbuvir and velpatasvir fixed dose combination	Drug	CDI-31244 + SOF/VEL

Primary outcome

Number of Subjects With Treatment Emergent Adverse Events
Time frame: 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
Number of Participants With Sustained Virologic Response (SVR) 12 Weeks After Treatment
Time frame: post-treatment Week 12
SVR12 is defined as HCV RNA < the lower limit of quantitation (LLOQ) at 12 weeks after treatment

1 secondary outcome

Number of Participants With Sustained Virologic Response (SVR) 24 Weeks After Discontinuation of Therapy
Time frame: post-treatment Week 24

Results and safety

Results posted to the registry on 28 Apr 2021, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
CDI-31244 + SOF/VEL	12	12

Primary outcome: Number of Subjects With Treatment Emergent Adverse Events

Time frame: Day 1 to Day 72. Count of participants. Unit: Participants

Measure	CDI-31244 + SOF/VEL n = 12
Value	10

Primary outcome: Number of Participants With Sustained Virologic Response (SVR) 12 Weeks After Treatment

Time frame: post-treatment Week 12. Count of participants. Unit: Participants

Measure	CDI-31244 + SOF/VEL n = 12
Value	8

1 secondary outcome is reported in the full results.

Adverse events

Time frame: from signing of informed consent to fours weeks after end of treatment (from Study Day 1 to Study Day 72). Other adverse events reported at 0% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
CDI-31244 + SOF/VEL	1 of 6 (16.7%)	10 of 12 (83.3%)	0 of 12

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 28 Apr 2021.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Individual participant dataSharing planned: No

Related trials for Chronic Hepatitis C

RecruitingObservational study
Evaluation of Patients With Liver Disease
Hepatitis D, Hepatitis C
RecruitingObservational study
"Constitution of a Biological Collection to Establish Preclinical Translational Models for the Study of Tumors and Chronic Liver Diseases".
Chronic Liver Disease and Cirrhosis, Liver Cancer
Active, not recruitingPhase 4
People With CHC Who Achieved a Sustained Virological Response Following Therapy With Direct Acting Antiviral Agents
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Active, not recruitingPhase 4
Sofosbuvir/Velpatasvir Treatment of Chronic Hepatitis C During Pregnancy
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Enrolling by invitationObservational study
Comparative Autoantibody and Immunologic Cell Marker Study
Autoimmune Diseases, Lupus Erythematosus, Systemic

Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Joel Chua, MD principal investigator

Institute of Human Virology, University of Maryland, Baltimore

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing CDI-31244 and SOF/VEL in people with Chronic Hepatitis C, run by Cocrystal Pharma, Inc. at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 28 Apr 2021. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 28 Apr 2021). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Number of Subjects With Treatment Emergent Adverse Events (time frame: Day 1 to Day 72). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT03501550.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Apr 2021; AzTrials last refreshed its copy on 30 Oct 2026.