AzTrials
AzTrials

Hepatitis C, ChronicPhase 3KW-136_IIINCT03995485

KW-136 With Sofosbuvir for Chinese Adults With Chronic Hepatitis C

A Phase 3 study testing KW-136 capsule and Sofosbuvir in people with Hepatitis C, Chronic, run by Kawin Technology Share-holding Co., Ltd. at 19 sites in China.

Completed

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

Official record
Search all trials

Trial summary

This study aimed to confirm efficacy and safety of KW-136, an investigational anti-hepatitis C virus (HCV) drug, combined with sofosbuvir for treatment of naive and experienced adults chronically infected with HCV. Read more about this study

Who is it for?
Ages 18 to 70 years
Conditions the study is for
Hepatitis C, Chronic
What is being tested?
KW-136 capsule and Sofosbuvir
Type of treatment
Pill or oral medicine
Could I receive a placebo?
No, everyone receives an active treatment
How many people
371 participants
Where
19 sitesChina
Study dates
7 Jun 2017to 7 Mar 2018
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 to 70 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • aged between 18 and 70 years (both inclusive) at the time of informed consenting and of either sex
  • with a body mass index (BMI) between 18 and 32 kg/m^2 (both inclusive)
  • chronically infected with HCV, namely, with positive anti-HCV, HCV RNA or genotyping results at least six (6) months before the screening, or with a liver biopsy confirming chronic hepatitis at most twelve (12) months before the screening or within the screening period
  • with anti-HCV positivity and at least once testing result with HCV RNA equaling to or above 10^4 IU/mL within the screening period
  • with gentoype 1, 2, 3, 4, 5, 6, mixed, indeterminate or other genotype by the centralized laboratory genotyping
  • no more than ten percent (10%) of the enrolled subjects having previously experienced interferon (defined as having received any regulatory agency approved or investigational interferon formulations, including pegylated and regular interferons at least six [6] months before the screening)
Show all 12Show fewer
  • having not previously experienced any other approved, investigational or unapproved direct antiviral agents against HCV of any source
  • having not previously experienced oral or injective ribavirin within three (3) months before the screening
  • no more than ten percent (10%) of the enrolled patients having advanced fibrosis or compensatory cirrhosis (as documented by liver transient elastography [FibroScan] within the screening period, or liver biopsy within twelve [12] months before the screening or within the screening period, with an evidence priority over FibroScan result and with the most recent biopsy prevailing in case of inconsistency between liver biopsy and FibroScan result), in accordance with the following definitions of liver disease: no advanced fibrosis or cirrhosis, with a liver stiffness modulus (LSM) below 9.6 kPa and/or F0-2 on fibrosis staging; advanced fibrosis, with a LSM equaling to or above 9.6 kPa but below 14.6 kPa and/or F3 on fibrosis staging; and cirrhosis, with a LSM equaling to or above 14.6 kPa and/or F4 on fibrosis staging
  • women of childbearing potential (including postmenopausal women at or under 50 years of age) with negative blood pregnancy test results, and subjects of childbearing potential (including male subjects and their female partners) having no childbearing plan and consenting to voluntarily use effective contraceptive measures from the screening until six (6) months after the end of treatment
  • lactating women consenting to discontinue nursing from the screening until six (6) months after the end of treatment
  • voluntarily participating in this trial and being able to understand and sign the informed consent form

Who cannot join

  • having previously experienced any investigational or experimental direct antiviral agents against HCV, including protease inhibitor, nonstructural protein (NS) 5A inhibitor or NS5B polymerase inhibitor, before the screening NS5B polymerase or NS5A inhibitors, before the screening
  • having previously experienced interferon-based antiviral regimens within six (6) months before the screening
  • having previously experienced oral or injective ribavirin within three (3) months before the screening
  • having previously experienced any systemic potent immunomodulatory agents, such as steroids or thymosin alfa, excluding nasal, inhalational, topical steroids and/or others, for more than two (2) weeks within six (6) months before the screening, or expected to be exposed to these agents during the study period
  • with hepatitis B virus surface antigen (HBsAg) or anti-human immunodeficient virus (HIV) positivity
  • with evidence of decompensatory liver function, including but not limited to total serum bilirubin (TBIL) above twice (2) of the upper limit of normal (ULN), serum albumin (ALB) below 35 g/L or prothrombin activity (PTA) below 60% confirmed on repeated testing, previous or present history of ascites, upper gastrointestinal bleeding and/or hepatic encephalopathy, or with a liver function reserve of Child-Pugh class B or C
Show all 27Show fewer
  • with primary liver cancer confirmed or evidenced by serum alfa-fetoprotein (AFP) above 100 ng/ml or liver imaging study showing suspected nodules
  • with a previous history of liver disease of other causes, including alcoholic liver disease, nonalcoholic steatohepatitis, drug-induced hepatitis, autoimmune hepatitis, Wilson disease or hemochromatosis
  • with serum alanine aminotransferase (ALT) or asparate aminotransferase (AST) above ten (10) times of the ULN confirmed on repeated testing
  • with white blood cell (WBC) count below 3×10^9 per liter, neutrophil count below 1.5×10^9 per liter (or below 1.25×10^9 per liter for cirrhotics), platelet count below 50×10^9 per liter, or hemoglobin below 100 g/L confirmed on repeated testing
  • with serum creatinine clearance (CLcr) below 50 ml/min using the Cockcroft-Gault formula confirmed on repeated testing
  • with poorly controlled diabetes mellitus (hemoglobin A1c [HbA1c] above 8.0% confirmed on repeated testing)
  • with psychiatric or neurologic disorders, including previous or family history of psychiatric disorders (especially depression, depressive state, epilepsy or hysteria)
  • with serious cardiovascular disorders, including uncontrolled hypertension (systolic blood pressure at or above 160 mmHg and/or diastolic blood pressure at or above 100 mmHg), heart insufficiency of New York Heart Association class III or above, history of myocardial infarction within six (6) months before the screening, history of percutaneous transluminal coronary angioplasty within six (6) months before the screening, unstable angina pectoris, or QTc interval (Fridericia correction formula QTc = QT×RR^-1/3) at or above 450 msec for males or 470 msec for females, second- or third-grade atrioventricular block or any other uncontrolled arrhythmias confirmed on repeated electrocardiography on screening
  • with serious hematologic disorders, such as anemia, hemophilia and others
  • with serious kidney diseases, such as chronic kidney disease, kidney insufficiency and others
  • with serious gastrointestinal disorders, such as peptic ulcer, colitis and others
  • with serious respirator disorders, such as active pulmonary tuberculosis, lung infection, chronic obstructive pulmonary disease, pulmonary interstitial disease and others
  • with active or suspected malignant tumors, or with a previous history of malignant tumors, excluding skin basal cell carcinoma or cervical carcinoma in situ, within five (5) years before the screening
  • with a history of major organ transplantation
  • with a hypersensitive predisposition or a known history of serious allergy, especially to the investigational products and substances
  • with a history of active alcohol or drug abuse within six (6) months before the screening
  • pregnant women or lactating women rejecting or unable to discontinue nursing
  • being unable to discontinue prohibited medications as defined by the protocol
  • having previously participated in clinical studies of any other drugs within three (3) months before the screening
  • being unable or unwilling to provide informed consent, or unable to follow the protocol requirements
  • with any other conditions of ineligibility at the discretion of the investigators

Trial locations and contacts

19 sites in 1 country.

19 sites in 1 country

China19 sites

  • Chinese PLA 302 Hospital

    Beijing, Beijing Municipality, 100039

  • Capital Medical University Affiliated Beijing Youyi Hospital

    Beijing, Beijing Municipality, 100050

  • Capital Medical University Affiliated Beijing You'an Hospital

    Beijing, Beijing Municipality, 100069

  • Capital Medical University Affiliated Beijing Ditan Hospital

    Beijing, Beijing Municipality, 100102

  • Jilin University First Hospital

    Changchun, Jilin, 130021

  • Sichuan Provincial People's Hospital

    Chengdu, Sichuan, 610072

  • Chinese PLA Third Military Medical University First Affiliated Hospital

    Chongqing, Chongqing Municipality, 400038

  • Sun Yat-sen University Affiliated Third University

    Guangzhou, Guangdong, 510630

  • Guangzhou Municipal Eighth People's Hospital

    Guanzhou, Guangdong, 510060

  • Ji'nan Municipal Hospital of Infectious Disease

    Ji'nan, Shandong, 250021

  • Liuzhou People's Hospital

    Liuzhou, Guangxi, 545006

  • Nanjing Municipal Second Hospital

    Nanjing, Jiangsu, 210003

  • Shenyang Municipal Sixth People's Hospital

    Shenyang, Liaoning, 110006

  • Xinjiang Uygur Autonomous Region Traditional Chinese Medicine Hospital

    Ürümqi, Xinjiang, 830000

  • Chongqing Sanxia Central Hospital

    Wanzhou, Chongqing Municipality, 404000

  • Huazhong University of Science and Technology Affiliated Tongji Hospital

    Wuhan, Hubei, 430030

  • Chinese PLA Fourth Military Medical University Tangdu Hospital

    Xi'an, Shaanxi, 710038

  • Yanbian University Affiliated Hosptial

    Yanbian, Jilin, 133000

  • He'nan Provincial Hospital of Infectious Disease (Zhengzhou Municipal Sixth People's Hospital)

    Zhengzhou, He'nan, 450015

Other trials in China

About this study

Official title: Evaluation of Efficacy and Safety of KW-136 Capsule Combined With Sofosbuvir Tablet for Treatment of Adult Chronic Hepatitis C: an Open-label, Multi-center, Phase 3 Study

This study aimed to confirm efficacy and safety of KW-136, an investigational anti-hepatitis C virus (HCV) drug, combined with sofosbuvir for treatment of naive and experienced adults chronically infected with HCV. Three hundred and sixty (360) non-cirrhotic and cirrhotic subjects were medicated with KW-136 60 mg daily and sofosbuvir 400 mg daily. The treatment course lasted 12 successive weeks; thereafter all the study participants entered into a 12-week treatment-free follow-up period and an additional 12-week extension treatment-free follow-up period.

Read the detailed description

It is estimated that China has a population of over 10 million infected with HCV and also a highly variable HCV genotype geographic distribution. A simple, universal, non-genotype-specific treatment regimen is preferred for anti-HCV treatment in clinical practice and public health. KW-136 and sofosbuvir are potent anti-HCV agents targeting at different HCV proteins, namely, nonstructural protein 5A and 5B, respectively. The combination regimen of KW-136 and sofosbuvir is expected to completely suppress HCV replication in subjects chronically infected with HCV and achieve a sustained virologic response (SVR12), namely, HCV not detected or below a predefined limit in plasma, 12 or 24 weeks after cessation of treatment.

In a previous phase 2 exploratory study, an all-oral, ribavirin-free regiment of KW-136, an investigational HCV NS5A inhibitor, combined with sofosbuvir, demonstrated a ~99% SVR12 in treatment-naive adult subjects chronically infected with major genotypes of HCV found in China, including those with compensatory cirrhosis. This phase 3 study aimed to confirm the efficacy and safety of this combined regimen in a large scale of target patient population, including interferon-experienced subjects. This simple, uniform regimen is expected to be the solution to HCV eradication in China from the perspective of public health.

Being tested
KW-136 capsule, Sofosbuvir
Keywords
Chronic hepatitis C, Hepatitis C virus, Eradication, KW-136, Sofosbuvir, Nonstructural protein 5A, Nonstructural protein 5B, Panogentypic regimen, Confirmatory study
Medical subject headings
Hepatitis C, Chronic, Hepatitis C

What participants receive

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

  • KW-136 capsuleDrug

    Also called Coblopasvir

    KW-136 60 mg was provided in a single capsule of 60 mg.

  • SofosbuvirDrug

    Sofosbuvir was provided in a single tablet of 400 mg.

Study groups in NCT03995485
Study groupRoleWhat they receive
KW-136+SOFExperimentalTreatment-naive and experienced subjects were medicated with KW-136 capsules 60 mg once daily and fixed-dose (400 mg once daily) sofosbuvir tablets for 12 successive weeks.
Receives: Drug: KW-136 capsule; Drug: Sofosbuvir

What is being measured

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

  1. Sustained virologic response at 12 weeks after end of treatment (SVR12)

    Percentage of subjects with plasma HCV not detected or below the lower limit of quantitation (15 IU/mL)

    Measured: 12 weeks after end of treatment

Secondary outcomes (6)

  1. Sustained virologic response at 4 weeks after end of treatment (SVR4)

    Percentage of subjects with plasma HCV not detected or below the lower limit of quantitation (15 IU/mL)

    Measured: 4 weeks after end of treatment

  2. Rapid virologic response at 1 week after initiation of treatment (RVR1)

    Percentage of subjects with plasma HCV not detected or below the lower limit of quantitation (15 IU/mL)

    Measured: 1 week after initiation of treatment

  3. Rapid virologic response at 2 weeks after initiation of treatment (RVR2)

    Percentage of subjects with plasma HCV not detected or below the lower limit of quantitation (15 IU/mL)

    Measured: 2 weeks after initiation of treatment

  4. Rapid virologic response at 4 weeks after initiation of treatment (RVR4)

    Percentage of subjects with plasma HCV not detected or below the lower limit of quantitation (15 IU/mL)

    Measured: 4 weeks after initiation of treatment

  5. Rapid virologic response at 8 weeks after initiation of treatment (RVR8)

    Percentage of subjects with plasma HCV not detected or below the lower limit of quantitation (15 IU/mL)

    Measured: 8 weeks after initiation of treatment

  6. Rapid virologic response at 12 weeks after initiation of treatment (RVR12)

    Percentage of subjects with plasma HCV not detected or below the lower limit of quantitation (15 IU/mL)

    Measured: 12 weeks after initiation of treatment

Timeline

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

  1. First posted24 Jun 2019
  2. Study start7 Jun 2017
  3. Primary completion25 Jan 2018
  4. Study completion7 Mar 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 3
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Model description
Single-arm, external (historic) control
Masking
None (open label)
Enrolment
371 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03995485
Sponsor's protocol ID
KYGL-2017-001
Other IDs
CTR20171654
Acronym
KW-136_III
Status last verified
Jun 2019
First submitted
20 Jun 2019
Last updated
25 Jun 2019
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No: No IPD plan is included in the study protocol.

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing KW-136 capsule and Sofosbuvir in people with Hepatitis C, Chronic, run by Kawin Technology Share-holding Co., Ltd. at 19 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 12 inclusion and 27 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 25 Jun 2019. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 19 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?

Sustained virologic response at 12 weeks after end of treatment (SVR12) (time frame: 12 weeks after end of treatment). 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 NCT03995485.

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 25 Jun 2019.

AzTrials uses cookies for analytics and advertising. You can accept or reject them; the site works either way. Privacy Policy.

Free account

Log in to keep searching

You’ve used your 3 free searches. AzTrials is free: log in or create a free account to keep searching clinical trials and save the ones you want to follow.

Create a free accountLog in