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Chronic HCV InfectionPhase 2NCT03458481

Phase 2 Study of Yimitasvir Phosphate Capsules

A Phase 2 study testing SOF and DAG181 in people with Chronic HCV Infection, run by Sunshine Lake Pharma Co., Ltd. at 17 sites in China.

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

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 Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Chronic HCV Infection
What is being tested?
SOF and DAG181
Type of treatment
Pill or oral medicine
Could I receive a placebo?
No, everyone receives an active treatment
How many people
129 participants
Where
17 sitesChina
Study dates
31 Jul 2017to 26 Sep 2018
Phase
Phase 2
Are there results?
None posted in the registry

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

  • 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.
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  • 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:
  • Treatment naive is defined as having never been exposed to approved or experimental HCV-specific direct-acting antiviral agents or prior treatment of HCV with interferon (with or without ribavirin);
  • Treatment experienced is defined as prior treatment failure to a regimen containing interferon (IFN-α,β or Peg-IFN±RBV) that was completed at least 2 months prior to screening. and the subject's medical records must include sufficient detail of prior virologic failure to allow for categorization of prior response, as either:
  • Non-Responder: Decrease of HCV RNA<2 log at week 12 compared to baseline; ii) Partially-Responder: Decrease of HCV RNA>2 log at week 12 compared to baseline, and detectable HCV RNA levels within week 12 and week 24; iii) Breakthrough/Relapse: Subject achieved undetectable HCV RNA levels (HCV RNA < LLOQ) during treatment, but did not achieve sustained virologic response (SVR); iv) Intolerance: Subjects have discontinued interferon-based treatment due to intolerance which proved by chief complaint or medical records.
  • Absence of cirrhosis is defined as any one of the following:
  • Liver biopsy within 2 years of Screening or at Screening showing absence of cirrhosis (e.g. Metavir score=0-3 or Ishak score<5), or
  • Fibroscan within 6 months of Screening or at Screening with a result of ≤12.5 kPa.
  • liver biopsy results will supersede fibroscan results and be considered definitive.
  • Subject must be able to comply with the dosing instructions for study drug administration and able to complete the study schedule of assessments.

Who cannot join

  • Subjects who meet any of the following exclusion criteria are not to be enrolled in this study:
  • 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;
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  • 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;
  • Albumin< 3.5 g/dL;
  • AFP>100 ng/mL; If 20 ng/mL≤AFP≤100 ng/mL, a liver ultrasound examination is required to exclude subjects suspected of hepatocellular carcinoma;
  • INR > 1.5 x ULN;
  • Hemoglobin<11 g/dL for female subjects; <12 g/dL for male subjects;
  • Platelets<90 x109/L;
  • Neutrophil absolute count< 1.5 ×109/L;
  • HbA1c > 8.5%;
  • Creatinine clearance (CLcr) <50 mL /min as calculated by the Cockcroft-Gault equation;
  • HBsAg serology test results were positive;
  • HIV antibody test results were positive.
  • Screening ECG with clinically significant abnormalities;
  • Prior exposure to approved or experimental HCV-specific direct-acting antiviral agent;
  • Use of any prohibited concomitant medications;
  • Significant drug allergy, or known hypersensitivity to DAG181, SOF and its metabolites, or formulation recipients;
  • A positive drug screen at screening will exclude subjects unless it can be explained by non-prescription drug or prescribed medication; the diagnosis and prescription must be approved by the investigator;
  • Pregnant or nursing female or male with pregnant female partner.

Trial locations and contacts

17 sites in 1 country.

17 sites in 1 country

China17 sites

  • Peking University First Hospital

    Beijing, Beijing Municipality, 100034

  • Peking University People's Hospital

    Beijing, Beijing Municipality, 100044

  • Beijing YouAn Hospital,Capital Medical University

    Beijing, Beijing Municipality, 100069

  • The First Hospital of Jilin University

    Changchun, Jilin, 130021

  • Xiangyan Hospital, Central South University

    Changsha, Hunan, 410008

  • West China Hospital, Sichuan University

    Chengdu, Sichuan, 610041

  • Guangzhou Eighth People's Hospital

    Guangzhou, Guangdong, 510060

  • Nanfang Hospital of Southern Medical University

    Guangzhou, Guangdong, 510515

  • Hainan General Hospital

    Haikou, Hainan, 570311

  • The First Hospital of Lanzhou University

    Lanzhou, Gansu, 730000

  • The First Affiliated Hospital of NanChang University

    Nanchang, Jiangxi, 330006

  • The Second Hospital of Nanjing

    Nanjing, Jiangsu, 210003

  • The Third Hospital of Hebei Medical University

    Shijiazhuang, Hebei, 050051

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

    Wuhan, Hubei, 430022

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

    Wuhan, Hubei, 430030

  • Renmin Hospital of Wuhan University

    Wuhan, Hubei, 430060

  • Tangdu Hospital

    Xi’an, Shanxi, 710038

Other trials in China

About this study

Official title: A Multicenter, Randomized, Parallel Assigned, Open-label Study to Investigate the Efficacy and Safety of Yimitasvir Phosphate (DAG181)/Sofosbuvir(SOF) Combination for 12 Weeks in Subjects With Chronic Genotype 1 HCV Infection

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

Read the detailed description

A phase 2, multicenter, randomized, parallel Assigned, open-label study to explore the safety, tolerability and antiviral activity of DAG181/SOF combination for 12 weeks in adult subjects with chronic genotype 1 HCV infection.

Approximately 120 HCV genotype 1 subjects without cirrhosis will be enrolled, treatment-experienced subjects are ≤20%, all subjects will be randomized (1:1) to one of the following two treatment groups by IWRS (Medidata Balance): a) DAG181 100 mg/ SOF 400 mg once daily for 12 weeks, b) DAG181 200 mg/ SOF 400 mg once daily for 12 weeks. Randomization will be stratified by "treatment-naive" or "treatment-experienced".

Being tested
SOF, DAG181
Keywords
Chronic Genotype 1 HCV Infection

What participants receive

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

  • SOFDrug

    Also called sofosbuvir, Sovaldi®

    400 mg tablet administered orally once daily

  • DAG181Drug

    Also called Yimitasvir

    Capsule administered orally once daily

Study groups in NCT03458481
Study groupRoleWhat they receive
SOF+DAG181 100 mgExperimentalPatients with genotype 1 HCV infection without cirrhosis will receive SOF+DAG181 100 mg for 12 weeks.
Receives: Drug: SOF; Drug: DAG181
SOF+DAG181 200 mgExperimentalPatients with genotype 1 HCV infection without cirrhosis will receive SOF+DAG181 200 mg for 12 weeks.
Receives: Drug: SOF; Drug: DAG181

What is being measured

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

  1. 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

    Measured: Posttreatment Week 12

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

    Measured: Up to posttreatment week 24

Secondary outcomes (6)

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

    SVR4,SVR8 and SVR24 were defined as HCV RNA < the lower limit of quantitation (LLOQ) at 4, 8 and 24 weeks after stopping study treatment, respectively.

    Measured: Posttreatment Weeks 4,8 and 24

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

    Measured: Baseline to week 12

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

    Measured: Baseline to week 12

  4. HCV RNA change from baseline

    Measured: Up to posttreatment week 24

  5. Percentage of subjects with virologic failure

    Virologic failure was defined as:

    1. On-treatment virologic failure: Breakthrough (confirmed HCV RNA ≥the lower limit of quantitation (LLOQ) after having previously had HCV RNA <the lower limit of quantitation (LLOQ) while on treatment), or Rebound (confirmed > 1 log10 IU/mL increase in HCV RNA from nadir while on treatment), or Non-response (HCV RNA persistently ≥the lower limit of quantitation (LLOQ) through 8 weeks of treatment);
    2. Virologic relapse: Confirmed HCV RNA ≥the lower limit of quantitation (LLOQ) during the posttreatment period having achieved HCV RNA <the lower limit of quantitation (LLOQ) at last on-treatment visit.

    Measured: Up to posttreatment week 24

  6. Viral resistance

    Viral resistance to DAG181 and/or SOF during treatment and after cessation of treatment

    Measured: Up to posttreatment week 24

Timeline

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

  1. First posted8 Mar 2018
  2. Study start31 Jul 2017
  3. Primary completion8 May 2018
  4. Study completion26 Sep 2018

Resources

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
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
129 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03458481
Sponsor's protocol ID
PCD-DDAG181PA-16-005
Status last verified
Mar 2020
First submitted
10 Feb 2018
Last updated
18 Mar 2020
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing SOF and DAG181 in people with Chronic HCV Infection, run by Sunshine Lake Pharma Co., Ltd. at 17 sites in China.

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 23 inclusion and 32 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 18 Mar 2020. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 17 sites in China. 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?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

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?

Percentage of subjects with sustained virologic response 12 weeks after discontinuation of therapy (SVR12) (time frame: Posttreatment Week 12). 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 NCT03458481.

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 18 Mar 2020.

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