Phase 2 Study of Yimitasvir Phosphate Capsules

NCT03458481 | Completed Phase 2

• 1 other identifier: PCD-DDAG181PA-16-005
• Study Type: interventional
• Target: 129
• Locations: 1 country
• Sites: 17

Brief Summary

The safety, tolerability and antiviral activity of DAG181/SOF in treatment-naive and treatment-experienced patients with chronic hepatitis C virus (HCV) genotype 1 infection

Conditions

Chronic HCV Infection

Keywords

Chronic Genotype 1 HCV Infection

Outcome Measures

Primary Outcomes (2)

• Percentage of subjects with sustained virologic response 12 weeks after discontinuation of therapy (SVR12)

  SVR12 was defined as HCV RNA \< the lower limit of quantitation (LLOQ) at 12 weeks after stopping study treatment

  Posttreatment Week 12

• Safety and tolerability were evaluated based on adverse event monitoring, laboratory tests, 12-lead ECG assessments, vital signs measurements and physical examinations.

  Up to posttreatment week 24

Secondary Outcomes (6)

• Percentage of subjects with sustained virologic response 4, 8 and 24 weeks after discontinuation of therapy (SVR4,SVR8 and SVR24)

  Posttreatment Weeks 4,8 and 24

• Percentage of subjects with HCV RNA < the lower limit of quantitation (LLOQ) while on treatment

  Baseline to week 12

• The time to first achieve "HCV RNA < the lower limit of quantitation (LLOQ)" while on treatment

  Baseline to week 12

• HCV RNA change from baseline

  Up to posttreatment week 24

• Percentage of subjects with virologic failure

  Up to posttreatment week 24

Study Arms (2)

SOF+DAG181 100 mg

EXPERIMENTAL

Patients with genotype 1 HCV infection without cirrhosis will receive SOF+DAG181 100 mg for 12 weeks.

Drug: SOF; Drug: DAG181

SOF+DAG181 200 mg

EXPERIMENTAL

Patients with genotype 1 HCV infection without cirrhosis will receive SOF+DAG181 200 mg for 12 weeks.

Drug: SOF; Drug: DAG181

Interventions

SOF DRUG

400 mg tablet administered orally once daily

Also known as: sofosbuvir, Sovaldi®

SOF+DAG181 100 mg; SOF+DAG181 200 mg

DAG181 DRUG

Capsule administered orally once daily

Also known as: Yimitasvir

SOF+DAG181 100 mg; SOF+DAG181 200 mg

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Willing and able to provide written informed consent;
• Male or female, age≥18 years;
• A female subject is eligible to enter the study if it is confirmed that she is:
• Of non-childbearing potential (i.e., women who have had a hysterectomy, have both ovaries removed or medically documented ovarian failure, or are postmenopausal-women \> 50 years of age with cessation (for≥12 months) of previously occurring menses), or
• Of childbearing potential (Women≤50 years of age with amenorrhea will be considered to be of childbearing potential). These women must have a negative serum pregnancy test at screening, and must use specific contraceptive methods from screening until 4 weeks after last dose of study drugs, such as complete abstinence from intercourse, vaginal ring, cervical cap or contraceptive diaphragm, IUD, etc.
• All male study subjects must agree to consistently and correctly use specific contraceptive methods with their female partner from screening until 4 weeks after last dose of study drugs(except of surgical sterilization), such as complete abstinence from intercourse, condom, and their female partner use contraceptives , vaginal ring , cervical cap or contraceptive diaphragm, IUD, etc.
• Male subjects must agree to refrain from sperm donation from the date of screening until 4 weeks after the last dose of study drugs;
• Body mass index (BMI)≥18.0 and≤32.0 kg/m2, and Weight≥40 kg;
• Confirmation of chronic HCV infection documented by either:
• A positive anti-HCV antibody test or positive HCV RNA or positive HCV genotyping test at least 6 months prior to the Baseline/Day 1 visit, or
• A liver biopsy performed prior to the Baseline/Day 1 visit with evidence of chronic HCV infection.
• Serological detection of anti-HCV antibodies was positive at screening;
• HCV RNA≥1×104 IU/mL at Screening;
• HCV genotype 1a, 1b, or mixed 1a/1b at screening as determined by the Central Laboratory;
• Classification as treatment naive or treatment experienced:

You may not qualify if:

• Current or prior history of any of the following:
• Clinical hepatic decompensation (i.e., ascites, encephalopathy or variceal hemorrhage);
• Chronic liver disease of a non-HCV etiology (Including but not limited to hemochromatosis, Wilson's disease,alfa-1 antitrypsin deficiency);
• Significant cardiac disease(Including but not limited to myocardial infarction, bradycardia) ;
• Significant pulmonary disease;
• Malabsorption syndrome or gastrointestinal disorder or post operative condition that could interfere with the absorption of the study drug;
• Central nervous system trauma, epilepsy, stroke or transient ischemic attack;
• Psychiatric illness or psychological disease or relevant medical history;
• Malignancy diagnosed before signing the informed consent form ( except for specific cancers that have been cured by surgical resection (basal cell skin cancer, etc) or cervical carcinoma in situ are allowed). subjects under evaluation for malignancy are not eligible;
• Solid organ transplantation;
• Subjects have any other medical disorder that may interfere with subjects treatment, assessment or compliance with the protocol.
• Subjects has the following laboratory parameters at screening:
• ALT \> 10×the upper limit of normal (ULN);
• AST \> 10×ULN;
• Total bilirubin\> 1.5 × ULN;

Sponsors & Collaborators

• Sunshine Lake Pharma Co., Ltd.: lead

Study Sites (17)

Peking University First Hospital

Beijing, Beijing Municipality, 100034, China

Location

Peking University People's Hospital

Beijing, Beijing Municipality, 100044, China

Location

Beijing YouAn Hospital,Capital Medical University

Beijing, Beijing Municipality, 100069, China

Location

The First Hospital of Lanzhou University

Lanzhou, Gansu, 730000, China

Location

Guangzhou Eighth People's Hospital

Guangzhou, Guangdong, 510060, China

Location

Nanfang Hospital of Southern Medical University

Guangzhou, Guangdong, 510515, China

Location

Hainan General Hospital

Haikou, Hainan, 570311, China

Location

The Third Hospital of Hebei Medical University

Shijiazhuang, Hebei, 050051, China

Location

Union Hospital Affiliated with Tongji Medical College of Huazhong University of Science and Technology

Wuhan, Hubei, 430022, China

Location

Tongji Hospital Affiliated to Tongji Medical College of Huazhong University Science & Technology

Wuhan, Hubei, 430030, China

Location

Renmin Hospital of Wuhan University

Wuhan, Hubei, 430060, China

Location

Xiangyan Hospital, Central South University

Changsha, Hunan, 410008, China

Location

The Second Hospital of Nanjing

Nanjing, Jiangsu, 210003, China

Location

The First Affiliated Hospital of NanChang University

Nanchang, Jiangxi, 330006, China

Location

The First Hospital of Jilin University

Changchun, Jilin, 130021, China

Location

Tangdu Hospital

Xi’an, Shanxi, 710038, China

Location

West China Hospital, Sichuan University

Chengdu, Sichuan, 610041, China

Location

MeSH Terms

Interventions

Sofosbuvir; yimitasvir

Intervention Hierarchy (Ancestors)

Uridine Monophosphate; Uracil Nucleotides; Pyrimidine Nucleotides; Pyrimidines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Nucleotides; Nucleic Acids, Nucleotides, and Nucleosides; Ribonucleotides

Study Officials

• Lai Wei, Doctor

  Peking University People's Hospital

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 10, 2018
• First Posted: March 8, 2018
• Study Start: July 31, 2017
• Primary Completion: May 8, 2018
• Study Completion: September 26, 2018
• Last Updated: March 18, 2020

Record last verified: 2020-03

Data Sharing

• IPD Sharing: Will not share

Locations

CN (17)