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Chronic HCV InfectionPhase 3NCT03487107

Phase 3 Study of Yimitasvir Phosphate Capsules

A Phase 3 study testing SOF and DAG181 in people with Chronic HCV Infection, run by Sunshine Lake Pharma Co., Ltd. at 35 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
362 participants
Where
35 sitesChina
Study dates
17 Apr 2018to 25 Jun 2019
Phase
Phase 3
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 negative urine pregnancy test at baseline before first dose of study drugs, and must use specific contraceptive methods from screening until 90 days after last dose of study drugs, such as complete abstinence from intercourse, vaginal ring, cervical cap or contraceptive diaphragm, IUD, etc.
  • All male subjects must agree to consistently and correctly use specific contraceptive methods with their female partner from screening until 90 days after last dose of study drugs(except for 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 90 days after the last dose of study drugs;
  • 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;
  • Absence of cirrhosis.

Who cannot join

  • Investigator assessed subjects have other clinically significant abnormalities (other than HCV), such as uncontrollable heart disease, respiratory, gastrointestinal, blood, nervous or other medical disorders, which may interfere with treatment, assessment, or compliance with the protocol;
  • Laboratory results outside of acceptable ranges at Screening;
  • HBsAg serology test results were positive at Screening;
  • HIV antibody test results were positive at Screening;
  • Prior exposure to approved or experimental HCV-specific direct-acting antiviral agent;
  • Pregnant female or male with pregnant female partner.

Trial locations and contacts

35 sites in 1 country.

35 sites in 1 country

China35 sites

  • Beijing Ditan Hospital Affiliated to Capital Medical University

    Beijing, Beijing Municipality, 100020

  • Peking University First Hospital

    Beijing, Beijing Municipality, 100034

  • Peking University People's Hospital

    Beijing, Beijing Municipality, 100044

  • Beijing Friendship Hospital，Capital Medical University

    Beijing, Beijing Municipality, 100050

  • Beijing YouAn Hospital,Capital Medical University

    Beijing, Beijing Municipality, 100069

  • The First Hospital of Jilin University

    Changchun, Jilin, 130021

  • Hunan Provincial People's Hospital

    Changsha, Hunan, 410000

  • Xiangya Hospital, Central South University

    Changsha, Hunan, 410008

  • West China Hospital, Sichuan University

    Chengdu, Sichuan, 610041

  • Sichuan Provincial People's Hospital

    Chengdu, Sichuan, 610072

  • The First Affiliated Hospital of Fujian Medical University

    Fuzhou, Fujian, 350005

  • Mengchao Hepatobiliary Hospital of Fujian Medical University

    Fuzhou, Fujian, 350025

  • 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 People's Liberation Army No.81 Hospital

    Nanjing, Jiangsu, 210002

  • The Second Hospital of Nanjing

    Nanjing, Jiangsu, 210003

  • Ruijin Hospital Affiliated to Shanghai Jiao Tong University School of Medicine

    Shanghai, Shanghai Municipality, 200020

  • Shanghai Public Health Clinical Center

    Shanghai, Shanghai Municipality, 201500

  • The Sixth People's Hospital of Shenyang

    Shenyang, Liaoning, 110006

  • The Third Hospital of Hebei Medical University

    Shijiazhuang, Hebei, 050051

  • The First Affiliated Hospital of Wenzhou Medical University

    Wenzhou, Zhejiang, 325000

  • The Central Hospital of Wuhan

    Wuhan, Hubei, 430010

  • 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

  • The Fifth People's Hospital of Wuxi

    Wuxi, Jiangsu, 214073

  • Tangdu Hospital

    Xi’an, Shanxi, 710038

  • The First Affiliated Hospital of Xi'an Jiaotong University

    Xi’an, Shanxi, 710061

  • The First Affiliated Hospital of Xinxiang Medical University

    Xinxiang, Henan, 453100

  • The Affiliated Hospital of Xuzhou Medical Hospital

    Xuzhou, Jiangsu, 221002

  • People's Hospital of Zhengzhou

    Zhengzhou, Henan, 450003

  • The Third People's Hospital of Zhenjiang

    Zhenjiang, Jiangsu, 212004

Other trials in China

About this study

Official title: A Multicenter, Single-arm, 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 III, multicenter, single-arm, open-label study to assess the safety, tolerability and antiviral activity of DAG181/SOF combination for 12 weeks in adult subjects with chronic genotype 1 HCV infection.

Approximately 360 HCV genotype 1 subjects without cirrhosis will be enrolled, treatment-experienced subjects are ≤20%. All subjects will receive DAG181 100 mg/ SOF 400 mg once daily for 12 weeks，with subsequent observation for 24 weeks after cessation of treatment.

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

    100 mg capsule administered orally once daily

Study groups in NCT03487107
Study groupRoleWhat they receive
SOF 400 mg+DAG181 100 mgExperimentalPatients with genotype 1 HCV infection without cirrhosis will receive SOF 400 mg+DAG181 100 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 is defined as HCV RNA < the lower limit of quantitation (LLOQ) at 12 weeks after discontinuation of therapy

    Measured: Posttreatment Week 12

  2. Safety and tolerability were evaluated based on adverse events

    Collecting all adverse events during the whole study

    Measured: Up to posttreatment week 24

Secondary outcomes (4)

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

    SVR4 and SVR24 were defined as HCV RNA < the lower limit of quantitation (LLOQ) at 4 and 24 weeks after discontinuation of therapy, respectively.

    Measured: Posttreatment Weeks 4 and 24

  2. HCV RNA change from baseline

    the quantification of HCV RNA during and after treatment compared with baseline

    Measured: Up to posttreatment week 24

  3. Percentage of subjects with virologic failure

    1. On-treatment virologic failure:
    2. confirmed HCV RNA ≥ the lower limit of quantitation (LLOQ) after having previously had HCV RNA <the lower limit of quantitation (LLOQ) while on treatment;
    3. confirmed ≥ 1 log10 IU/mL increase in HCV RNA from nadir while on treatment;
    4. HCV RNA persistently ≥the lower limit of quantitation (LLOQ) through 8 weeks of treatment.
    5. Virologic relapse:
    6. 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

  4. Percentage of subjects with viral resistance to DAG181 and/or SOF

    Monitoring HCV virus resistance at baseline, during and after 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 posted3 Apr 2018
  2. Study start17 Apr 2018
  3. Primary completion28 Mar 2019
  4. Study completion25 Jun 2019

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 3
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
362 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03487107
Sponsor's protocol ID
PCD-DDAG181PA-16-007
Status last verified
Mar 2020
First submitted
26 Mar 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 3 study testing SOF and DAG181 in people with Chronic HCV Infection, run by Sunshine Lake Pharma Co., Ltd. at 35 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 15 inclusion and 6 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 35 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 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

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 NCT03487107.

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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