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Hepatitis C, ChronicPhase 2/3NCT04070235

SH229 Tablets Combined With Daclatasvir Dihydrochloride Tablets in Treatment Adult Patients With Chronic Hepatitis C

A Phase 2/3 study testing SH229 tablets and Daclatasvir dihydrochloride in people with Hepatitis C, Chronic, run by Nanjing Sanhome Pharmaceutical, Co., Ltd. at 1 site in China.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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Trial summary

Phase II: Exploring the efficacy and safety of different doses of SH229 tablets combined with fixed-dose Daclatasvi dihydrochloride (DCV) tablets in the treatment of adult patients with chronic hepatitis C for 12 weeks, providing a basis for the design and implementation of phase III clinical trials. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Hepatitis C, Chronic
What is being tested?
SH229 tablets and Daclatasvir dihydrochloride
Type of treatment
Pill or oral medicine
Could I receive a placebo?
No, everyone receives an active treatment
How many people
440 participants
Where
1 siteChina
Study dates
29 Mar 2019to Aug 2020
Phase
Phase 2/3
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.
  • Subjects should be able to follow the instructions for the study drug and be able to complete screening, on-treatment, and post treatment assessments.
  • Male or female, age above 18 years
  • Body mass index ( BMI ) between 18 and 32 kg/m2 at Screening.
  • Confirmation of chronic HCV infection, which meets one of the following: (a) positive for anti-HCV antibodies, HCV RNA or HCV genotyping results within ≤ 6 months of screening, or (b) liver biopsy ≤ 12 months of screening.
  • HCV RNA above 10^4 IU/mL at Screening by the Central Laboratory.
Show all 13Show fewer
  • HCV genotype 1, 2, 4, 5, 6, or indeterminate assessed at Screening by the Central Laboratory.
  • Classification as treatment naïve or treatment experienced (approximately 20% of subjects may be treatment experienced):
  • Treatment naïve is defined as having never been exposed to approved or experimental HCV-specific direct-acting antiviral agents ( DAA ) or prior treatment of HCV with interferon either with or without RBV.
  • Treatment experienced is defined as prior treatment failure to a regimen containing IFN-based antiviral (INF-α, β or PEG-IFN ± ribavirin) and met one of the following: (i) Non-Responder: Subject did not achieve undetectable HCV RNA levels while ontreatment,, (ii) Relapse/Breakthrough: Subject achieved undetectable HCV RNA levels duringtreatment but did not achieve SVR, (iii) Terminate the treatment , according to associated-HCV therapy adverse events by subject reported or medical records demonstrated.
  • Cirrhosis Determination (approximately 20% of subjects may have cirrhosis)：
  • Cirrhosis is defined as any one of the following: (i) Fibroscan with a result of >12.5 kPa within ≤ 6 months of screening, (ii) Liver biopsy showing cirrhosis within ≤ 12 months of screening.
  • Absence of cirrhosis is defined as any one of the following:(i) Fibroscan with a result of ≤ 12.5 kPa within ≤ 6 months of screening, (ii) Liver biopsy showing non-cirrhosis within ≤ 12 months of screening.

Who cannot join

  • Exposure nucleotide analogue including HCV NS3-4A inhibitor, HCV NS5B inhibitor or any HCV NS5A inhibitor before baseline/Day 1.
  • Receive IFN-based antiviral therapy within 6 months prior to baseline/day 1.
  • Oral or injection of RBV within 3 months prior to baseline/Day 1.
  • Systemic use of potent immunomodulators (eg, adrenocortical hormone, thymosin alpha, etc.) for more than 2 weeks prior to baseline/day 1, or expected to be exposed to these agents during the study.
  • Use of amiodarone within 2 months before baseline/day 1.
  • Positive for Hepatitis B surface antigen (HBsAg) or anti-human immunodeficiency virus antibody (HIV Ab) at screening.
Show all 27Show fewer
  • Evidence of decompensatory liver function, including but not limited to total serum bilirubin (TBIL) above twice 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.
  • Primary liver cancer confirmed or evidenced by serum alfa-fetoprotein (AFP) above 100 ng/ml or liver imaging study showing suspected nodules.
  • liver disease of a non-HCV etiology (e.g. alcoholic liver disease, nonalcoholic steatohepatitis, drug-induced hepatitis, autoimmune hepatitis, Wilson disease or hemochromatosis, etc.).
  • Subjects has the following laboratory parameters at screening: ALT or AST>10×ULN, WBC < 3×109 /L, ANC< 1.5×109 /L（or < 1.25×109 /L for cirrhotics ), PLT< 50×109 /L, Hb < 100 g/L, INR > 1.5×ULN, CLcr < 50 mL/min（calculated by the Cockcroft-Gault equation ）.
  • Uncontrolled diabetes mellitus (HbA1c > 8.0% at screening).
  • Uncontrolled hyperthyroidism or diminished.
  • Psychiatric or neurologic disorders, including previous or family history of psychiatric disorders (especially depression, depressive state, epilepsy or hysteria).
  • Serious cardiovascular disorders, including uncontrolled hypertension (systolic blood pressure ≥ 160 mmHg and/or diastolic blood pressure ≥100 mmHg), heart insufficiency of New York Heart Association class III or above, history of myocardial infarction within 6 months before the screening, history of percutaneous transluminal coronary angioplasty within 6 months before the screening, unstable angina pectoris, or QTc interval (Fridericia correction formula QTc = QT×RR^-1/3) at or above 450 mse, second- or third-grade atrioventricular block or any other uncontrolled arrhythmias confirmed on repeated electrocardiography on screening.
  • Serious hematologic disorders (e.g. anemia, hemophilia, etc.).
  • Serious kidney diseases (e.g. chronic kidney disease, kidney insufficiency, etc.).
  • Serious gastrointestinal disorders, (e.g. peptic ulcer, colitis, etc.) or post operative condition that could interfere with the absorption of the study drug.
  • Serious respirator disorders, (e.g. active pulmonary tuberculosis, lung infection, chronic obstructive pulmonary disease, pulmonary interstitial disease, etc.).
  • Malignancy within the 5 years prior to screening, with the exception of specific cancers that have been cured by surgical resection (basal cell skin cancer, etc).
  • Solid organ transplantation.
  • Hypersensitive predisposition or a known history of serious allergy, especially to the investigational products and substances.
  • Positive urine drug screening at screening, or Clinically-relevant alcohol or drug abuse within 12 months of screening, and compliance and effectiveness evaluated by the investigator.
  • Positive screening serum pregnancy test or baseline/day 1 serum or urine pregnancy test, and women are confirmed in pregnancy or lactation.
  • Women of childbearing age (menopausal women aged ≤ 50 years old are also considered to have fertility), or partners who are women of childbearing age cannot comply with voluntary effective contraceptive measures during the 6 months from screening to the last dose of test drug.
  • Use of any prohibited concomitant medications as described in protocol.
  • Participated in clinical studies or previously participated within 3 months prior to baseline/Day 1.
  • Conditions which investigator judges that it is not suitable for enrollment.

Trial locations and contacts

1 site in 1 country.

China1 site

  • The First Hospital of Jilin University

    Jilin, Jiangsu, 130021

Other trials in China

About this study

Official title: A Multicenter, Open-Label Study to Evaluate the Efficacy and Safety of SH229 Tablets Combined With Daclatasvir Dihydrochloride Tablets in Treatment Adult Patients With Chronic Hepatitis C

Phase II: Exploring the efficacy and safety of different doses of SH229 tablets combined with fixed-dose Daclatasvi dihydrochloride (DCV) tablets in the treatment of adult patients with chronic hepatitis C for 12 weeks, providing a basis for the design and implementation of phase III clinical trials.

Phase III: Confirmation of the efficacy and safety of SH229 tablets combined with Daclatasvi dihydrochloride (DCV) tablets in the treatment of adult patients with chronic hepatitis C for 12 weeks, providing a sufficient basis for drug registration and clinical use.

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. The combination regimen of SH229 and DCV is expected to completely suppress HCV replication in subjects chronically infected with HCV and achieve a sustained virologic response.

Being tested
SH229 tablets, Daclatasvir dihydrochloride
Keywords
Hepatitis C virus, SH229
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.

  • SH229 tabletsDrug

    Also called Holybuvir

    SH229 400 mg was provided in 4 tablets, 100mg each；SH229 600 mg was provided in 6 tablets , 100mg each；SH229 800 mg in was provided in 8tablets , 100mg each。

  • Daclatasvir dihydrochlorideDrug

    Also called DAKLINZA

    Daclatasvir dihydrochloride was provided in a single tablet of 60 mg.

Study groups in NCT04070235
Study groupRoleWhat they receive
SH229/DCV 400mg/60mgExperimentalHCV GT 1-6 participants were medicated with SH229 tablets 400 mg once daily and DCV tablets 60 mg once daily QD (n=40) for 12weeks
Receives: Drug: SH229 tablets; Drug: Daclatasvir dihydrochloride
SH229/DCV 600mg/60mgExperimentalHCV GT 1-6 participants were medicated with SH229 tablets 600 mg once daily and DCV tablets 60 mg once daily (n=40).
Receives: Drug: SH229 tablets; Drug: Daclatasvir dihydrochloride
SH229/DCV 800mg/60mgExperimentalHCV GT 1-6 participants were medicated with SH229 tablets 800 mg once daily and DCV tablets 60 mg once daily (n=40).
Receives: Drug: SH229 tablets; Drug: Daclatasvir dihydrochloride
SH229/DCVExperimentalHCV GT 1-6 participants were medicated with SH229 tablets 400 mg,600 mg or 800 mg once daily and DCV tablets 60 mg once daily
Receives: Drug: SH229 tablets; Drug: Daclatasvir dihydrochloride

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 (7)

  1. Rapid virologic response at 4 week 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 week after initiation of treatment

  2. 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

  3. 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

  4. Sustained virologic response at 24 weeks after end of treatment (SVR24)

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

    Measured: 24 weeks after end of treatment

  5. Virologic breakthrough

    Percentage of subjects with on-treatment re-detected plasma HCV RNA after HCV RNA below the lower limit of quantitation

    Measured: 2, 4, 8 and 12 weeks after initiation of treatment

  6. Virologic relapse

    Percentage of subjects with off-treatment re-detected plasma HCV RNA after end-of-treatment HCV RNA below the lower limit of quantitation

    Measured: 4 and 12 weeks after end of treatment

  7. Antiviral effects of SH229 tablets combined with Daclatasvi dihydrochloride (DCV) tablets , as measured by HCV RNA levels

    To evaluate the kinetics of circulating HCV RNA during treatment and after cessation of treatment

    Measured: Up to 36 weeks

Timeline

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

  1. First posted28 Aug 2019
  2. Study start29 Mar 2019
  3. Primary completionDec 2019 (estimated)
  4. Study completionAug 2020 (estimated)

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 2/3
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Model description
Phase 2 is parallel;Phase 3 is single group
Masking
None (open label)
Enrolment
440 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04070235
Sponsor's protocol ID
SHC005-II/III-01
Status last verified
Aug 2019
First submitted
11 Aug 2019
Last updated
28 Aug 2019
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • Hua R, Kong F, Li G, Wen X, Zhang Y, Yang X, Meng C, Xie W, Jiang Y, Wang X, Han X, Huang Y, Mao Q, Wang J, Guan Y, Chen J, Ma Y, Xiong Q, Ma H, Yan X, Rao H, Zhao Y, Sun T, Zhu L, Mao X, Lian J, Deng G, Xin Y, Wang Y, Ye Y, Xu B, Gao H, Tan Y, Li D, Yang D, Su M, Zhang X, Min J, Shi X, Wei L, Niu J. Alfosbuvir plus Daclatasvir for Treatment of Chronic Hepatitis C Virus Infection in China. Infect Dis Ther. 2023 Nov;12(11):2595-2609. doi: 10.1007/s40121-023-00872-4. Epub 2023 Oct 19.

    PubMed 37856013

  • Hua R, Kong F, Wen X, Xiong Q, Chen J, Meng C, Ma H, Tan Y, Huang Y, Jiang Y, Guan Y, Mao X, Wang J, Xin Y, Gao H, Xu B, Li C, Wu Q, Zhang X, Wang Z, Zhao L, Zhang Y, Li G, Niu J. Efficacy and safety of alfosbuvir plus daclatasvir in Chinese patients with hepatitis C virus genotypes 1, 2, 3, and 6 infection: An open-label, phase 2 study. J Viral Hepat. 2022 Jun;29(6):455-464. doi: 10.1111/jvh.13650. Epub 2022 Apr 8.

    PubMed 35080256

Questions about this trial

What is this clinical trial studying?

A Phase 2/3 study testing SH229 tablets and Daclatasvir dihydrochloride in people with Hepatitis C, Chronic, run by Nanjing Sanhome Pharmaceutical, Co., Ltd. at 1 site 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 13 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: status not confirmed, as of the sponsor's last update on 28 Aug 2019. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site 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 combined 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.

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?

Results are not available in the source record.

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 NCT04070235, which also lists 2 linked publications.

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 28 Aug 2019.

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