AzTrials
AzTrials

Hepatitis C, ChronicPhase 2KW-136_IINCT03416491

Safety and Efficacy of KW-136 and Sofosbuvir for Treatment of Chronic Hepatitis C

A Phase 2 study testing KW-136 and Sofosbuvir in people with Hepatitis C, Chronic, run by Kawin Technology Share-holding Co., Ltd. at 12 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 evaluate the safety and efficacy of KW-136, an investigational anti-hepatitis C virus (HCV) drug, combined with sofosbuvir for treatment of Chinese adults chronically infected with HCV. Read more about this study

Who is it for?
Ages 18 to 65 years
Conditions the study is for
Hepatitis C, Chronic
What is being tested?
KW-136 and Sofosbuvir
Type of treatment
Pill or oral medicine
Could I receive a placebo?
No, everyone receives an active treatment
How many people
110 participants
Where
12 sitesChina
Study dates
15 Feb 2017to 8 Nov 2017
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 to 65 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • aged between 18 and 65 years (inclusive) at the time of informed consenting and of either sex
  • with a body mass index (BMI) between 18 and 30 kg/m^2 (inclusive)
  • chronically infected with HCV, namely, with positive anti-HCV, HCV RNA or genotyping results at least six (6) months before the baseline, or with a liver biopsy confirming chronic hepatitis at most twelve (12) months before the baseline or during the screening period
  • anti-HCV positivity and at least once testing result with HCV RNA equaling to or above 10^4 IU/mL
  • genotyped to be gentoype (GT-1) or non-GT-1(including GT-2, 3, 6 or others) by the centralized laboratory
  • naive to anti-HCV treatment, defined as being not previously treated with any interferon (including interferon alfa or beta or peginterferon), ribavirin, or other approved, investigational or any other not approved anti-HCV regimens of any source
Show all 9Show fewer
  • with or without cirrhosis (cirrhosis defined as FibroScan liver stiffness modulus (LSM) at least 14.6 kPa on screening, or liver biopsy confirming presence of cirrhosis within twelve (12) months before screening or within screening; no cirrhosis defined as FibroScan LSM below 14.6 kPa or liver biopsy confirming absence of cirrhosis within twelve (12) before screening or within screening; liver biopsy result takes priority over FibroScan LSM)
  • women of childbearing potential (including postmenopausal women at or under 50 years of age) with negative blood pregnancy test results; subjects of childbearing potential (including male subjects and their female partners) have no childbearing plan from screening, initiation of treatment until six (6) months after end of treatment and consent to use effective contraceptive measures
  • voluntary participation in the study and being able to understand and sign the informed consent form

Who cannot join

  • having previously used any investigational or experimental direct antiviral agents against HCV, including protease, NS5B polymerase or NS5A inhibitors, before screening
  • having received any interferon-based anti-HCV regimens before screening
  • having been exposed to any systemic potent immunomodulators , such as steroids or thymosin alfa (excluding use of nasal, inhalational, topical steroids and/or others) for more than two weeks within six (6) months before screening, or anticipated 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; emergence of ascites, upper gastrointestinal bleeding and/or hepatic encephalopathy; with liver function reserve Child-Pugh class B or C
  • with primary liver cancer confirmed or evidenced by serum alfa-fetoprotein above 100 ng/ml or liver imaging study showing suspected nodules
Show all 26Show fewer
  • 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 alaine aminotransferase (ALT) or asparate aminotransferase (AST) above ten (10) times of ULN confirmed on repeated testing
  • with white blood cell (WBC) count below 3x10^9 per liter, neutrophil count below 1.5x10^9 per liter (or below 1.25x10^9 per liter for cirrhotics), platelet count below 50x10^9 per liter, or hemoglobin below 120 g/L (for males) or 110 g/L (for females) confirmed on repeated testing
  • with serum creatinine clearance (CLcr) below 50 ml/min using the Cockcroft-Gault formula confirmed on repeated testing
  • with uncontrolled diabetes mellitus (hemoglobin A1c[HbA1c] above 7.0% 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 screening, history of percutaneous transluminal coronary angioplasty within six (6) months before screening, unstable angina pectoris, QTc interval (Fridericia correction formula QTc = QTxRR^-1/3) at or above 450 msec or 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 screening
  • with a history of major organ transplantation
  • being known to be severely hypersensitive or allergic to any drugs, especially the testing medications and other constituents
  • with a history of active alcohol or drug abuse within six (6) months before screening
  • being pregnant or lactating
  • being unable to discontinue prohibited medications as defined by the protocol
  • having participated in any other clinical studies within three (3) months before screening
  • being unable or unwilling to provide informed consent or unable to follow the protocol requirements
  • any other conditions of excluding a potential participant at the discretion of the investigators

Trial locations and contacts

12 sites in 1 country.

12 sites in 1 country

China12 sites

  • Peking University People's Hospital

    Beijing, Beijing Municipality, 100044

  • Capital Medical University Affiliated Beijing Youyi Hospital

    Beijing, Beijing Municipality, 100050

  • Capital Medical University Affiliated Beijing You'an Hospital

    Beijing, Beijing Municipality, 100069

  • Jilin University First Hospital

    Changchun, Jilin, 130021

  • Chinese PLA Third Military Medical University First Affiliated Hospital

    Chongqing, Chongqing Municipality, 400038

  • Dalian Municipal Sixth People's Hospital

    Dalian, Liaoning, 450015

  • Guangzhou Municipal Eighth People's Hospital

    Guanzhou, Guangdong, 510060

  • Ji'nan Municipal Hospital of Infectious Disease

    Ji'nan, Shandong, 250021

  • Nanjing Municipal Second Hospital

    Nanjing, Jiangsu, 210003

  • Qingdao Municipal Hospital

    Qingdao, Shandong, 266011

  • Shenyang Municipal Sixth People's Hospital

    Shenyang, Liaoning, 110006

  • 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 Plus Sofosbuvir for Treatment-naive Adults Chronically Infected With Hepatitis C Virus: a Randomized, Open-label, Multicenter Phase 2 Trial

This study aimed to evaluate the safety and efficacy of KW-136, an investigational anti-hepatitis C virus (HCV) drug, combined with sofosbuvir for treatment of Chinese adults chronically infected with HCV. Thirty (30) non-cirrhotic subjects were medicated with KW-136 30 mg daily, 60 non-cirrhotic subjects with KW-136 60 mg daily, and 30 cirrhotic subjects with KW-136 60 mg daily; all the 120 subjects received sofosbuvir 400 mg daily. The treatment course lasted 12 successive weeks and thereafter all the study participants entered into a 12-week 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, namely, HCV not detected or below a predefined limit in plasma, 12 or 24 weeks after cessation of treatment.

As KW-136 and sofosbuvir are both pan-genotypic anti-HCV agents (in simple words, effective for all known common genotypes of HCV), the combination of these two agents is also supposed to be efficacious for treatment of subjects chronically infected with HCV of all major genotypes and subtypes. An apparent clinical benefit of this pan-genotypic anti-HCV treatment regimen is that no complex, delicate HCV genotype sequencing is required before initiation of treatment to determine genotype-specific treatment alternatives of choice. This advantage is of great significance in the primary care setting.

Being tested
KW-136, Sofosbuvir
Keywords
Chronic hepatitis C, Hepatitis C virus, KW-136, sofosbuvir, nonstructural protein 5A, nonstructural protein 5B, panogentypic regimen
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-136Drug

    Also called Coblopasvir

    KW-136 30 mg was provided in 3 capsules, 10 mg each, and KW-136 60 mg in a single capsule of 60 mg.

  • SofosbuvirDrug

    Sofosbuvir was provided in a single tablet of 400 mg.

Study groups in NCT03416491
Study groupRoleWhat they receive
NC_30ExperimentalNon-cirrhotic subjects were medicated with KW-136 capsules 30 mg once daily and fixed-dose (400 mg once daily) sofosbuvir tablets for 12 successive weeks.
Receives: Drug: KW-136; Drug: Sofosbuvir
NC_60ExperimentalNon-cirrhotic 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; Drug: Sofosbuvir
LC_60ExperimentalCirrhotic 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; 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 posted31 Jan 2018
  2. Study start15 Feb 2017
  3. Primary completion17 Sep 2017
  4. Study completion8 Nov 2017

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
Model description
parallel, stratified assignment
Masking
None (open label)
Enrolment
110 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03416491
Sponsor's protocol ID
BJKY-2016-006
Other IDs
CTR20170073
Acronym
KW-136_II
Status last verified
Jan 2018
First submitted
24 Jan 2018
Last updated
31 Jan 2018
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.

Publications

  • Rao H, Song G, Li G, Yang Y, Wu X, Guan Y, Mao Q, Jiang X, Wang C, Zhang Y, Jia J, Guo X, Li C, Ning J, Qin H, Pan H, Wei L. Safety and efficacy of coblopasvir and sofosbuvir in patients with genotypes 1, 2, 3 and 6 HCV infections without or with compensated cirrhosis. J Viral Hepat. 2020 Jan;27(1):45-51. doi: 10.1111/jvh.13208. Epub 2019 Oct 2.

    PubMed 31520460

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing KW-136 and Sofosbuvir in people with Hepatitis C, Chronic, run by Kawin Technology Share-holding Co., Ltd. at 12 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 9 inclusion and 26 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 31 Jan 2018. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 12 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?

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 NCT03416491, which also lists 1 linked publication.

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 31 Jan 2018.

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