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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
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| CDI-31244 + SOF/VEL | Experimental | CDI-31244 in combination with SOF/VEL |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| CDI-31244 | Drug | investigational drug |
|
|
| Measure | Description | Time Frame |
|---|---|---|
| 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 | 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 | post-treatment Week 12 |
| Measure | Description | Time Frame |
|---|---|---|
| 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 | post-treatment Week 24 |
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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
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| Name | Affiliation | Role |
|---|---|---|
| Joel Chua, MD | Institute of Human Virology, University of Maryland, Baltimore | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Institute of Human Virology University of Maryland | Baltimore | Maryland | 21201 | United States |
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| ID | Title | Description |
|---|---|---|
| FG000 | 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 |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
subjects who received 2 wks of CDI-31244 with 6 wks of SOF and VEL
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| ID | Title | Description |
|---|---|---|
| BG000 | Subjects | number of subjects in the study |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | 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 | Posted | Count of Participants | Participants | Day 1 to Day 72 |
|
|
from signing of informed consent to fours weeks after end of treatment (from Study Day 1 to Study Day 72)
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | 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 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Abortion spontaneous | Pregnancy, puerperium and perinatal conditions | MedDRA 22.1 | Systematic Assessment |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Headache | Nervous system disorders | MedDRA 22.1 | Systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Luz Pascual | Cocrystal Pharma Inc | 9083611678 | lpascual@cocrystalpharma.com |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot | Yes | No | No | Study Protocol | May 22, 2018 | Mar 31, 2021 | Prot_000.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan | Jan 7, 2019 | Mar 31, 2021 | SAP_001.pdf |
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| ID | Term |
|---|---|
| D019698 | Hepatitis C, Chronic |
| ID | Term |
|---|---|
| D006526 | Hepatitis C |
| D000086982 | Blood-Borne Infections |
| D003141 | Communicable Diseases |
| D007239 | Infections |
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| ID | Term |
|---|---|
| C000611331 | sofosbuvir-velpatasvir drug combination |
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| SOF/VEL | Drug | sofosbuvir and velpatasvir fixed dose combination |
|
|
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Ethnicity (NIH/OMB) | Count of Participants | Participants | No |
|
| Race (NIH/OMB) | Count of Participants | Participants |
|
| Region of Enrollment | Count of Participants | Participants |
|
| HCV load | Median | Standard Deviation | log10 IU/mL |
|
|
| Primary | 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 | Posted | Count of Participants | Participants | post-treatment Week 12 |
|
|
|
| Secondary | 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 | Posted | Count of Participants | Participants | post-treatment Week 24 |
|
|
|
| 0 |
| 12 |
| 1 |
| 6 |
| 10 |
| 12 |
| Nausea | Gastrointestinal disorders | MedDRA 22.1 | Systematic Assessment |
|
| Back pain | Musculoskeletal and connective tissue disorders | MedDRA 22.1 | Systematic Assessment |
|
| Diarrhea | Gastrointestinal disorders | MedDRA 22.1 | Systematic Assessment |
|
| Nasopharyngitis | Infections and infestations | MedDRA 22.1 | Systematic Assessment |
|
| Abdominal distention | Gastrointestinal disorders | MedDRA 22.1 | Systematic Assessment |
|
| Bunion operation | Surgical and medical procedures | MedDRA 22.1 | Systematic Assessment |
|
| Contusion | Injury, poisoning and procedural complications | MedDRA 22.1 | Systematic Assessment |
|
| Cough | Respiratory, thoracic and mediastinal disorders | MedDRA 22.1 | Systematic Assessment |
|
| Dizziness | Nervous system disorders | MedDRA 22.1 | Systematic Assessment |
|
| Fatigue | General disorders | MedDRA 22.1 | Systematic Assessment |
|
| Joint Injury | Injury, poisoning and procedural complications | MedDRA 22.1 | Systematic Assessment |
|
| Musculoskeletal pain | Musculoskeletal and connective tissue disorders | MedDRA 22.1 | Systematic Assessment |
|
| Myalgia | Musculoskeletal and connective tissue disorders | MedDRA 22.1 | Systematic Assessment |
|
| Pain in extremity | Musculoskeletal and connective tissue disorders | MedDRA 22.1 | Systematic Assessment |
|
| Peripheral swelling | Musculoskeletal and connective tissue disorders | MedDRA 22.1 | Systematic Assessment |
|
| Plantar fasciitis | Musculoskeletal and connective tissue disorders | MedDRA 22.1 | Systematic Assessment |
|
| Pruritus | Skin and subcutaneous tissue disorders | MedDRA 22.1 | Systematic Assessment |
|
| Rash pruritic | Skin and subcutaneous tissue disorders | MedDRA 22.1 | Systematic Assessment |
|
| Sinus congestion | Respiratory, thoracic and mediastinal disorders | MedDRA 22.1 | Systematic Assessment |
|
| Syncope | Nervous system disorders | MedDRA 22.1 | Systematic Assessment |
|
| Toothache | Gastrointestinal disorders | MedDRA 22.1 | Systematic Assessment |
|
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| D006525 |
| Hepatitis, Viral, Human |
| D014777 | Virus Diseases |
| D018178 | Flaviviridae Infections |
| D012327 | RNA Virus Infections |
| D006521 | Hepatitis, Chronic |
| D006505 | Hepatitis |
| D008107 | Liver Diseases |
| D004066 | Digestive System Diseases |
| D002908 | Chronic Disease |
| D020969 | Disease Attributes |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |