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HCV InfectionPhase 2NCT03794258

Triple or Quadruple Combination DAAs Treatment for Subjects With HCV GT 1b Infection

A Phase 2 study testing SOF+DCV+CDI-31244 and SOF+DCV+CDI-31244+ASV in people with HCV Infection, run by Humanity & Health Medical Group Limited at 1 site in Hong Kong.

Withdrawn

Withdrawn. The study stopped before anyone enrolled.

Official record
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Trial summary

This is a phase 2a, open-label, randomized study. The study is designed to test the hypothesis that the nucleoside inhibitor sofosbuvir combined with NS5A inhibitor daclatasvir and NS5B non-nucleoside inhibitor CDI-31244 with/without the protease inhibitor asunaprevir will result in high SVR rate with a shortened… Read more about this study

Who is it for?
Ages 18 to 70 years
Conditions the study is for
HCV Infection
What is being tested?
SOF+DCV+CDI-31244 and SOF+DCV+CDI-31244+ASV
Type of treatment
Pill or oral medicine
Could I receive a placebo?
No, everyone receives an active treatment
How many people
0 participants
Where
1 siteHong Kong
Study dates
1 May 2019to 30 Apr 2020
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 70 years
  • 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 18-70 years.
  • HCV genotype 1b infection as determined by the Laboratory. Any non-definitive results will exclude the subject from study participation.
  • HCV RNA level ≥ 10,000 IU/mL and < 10,000,000 IU/mL.
  • No evidence of cirrhosis. Cirrhosis defined as any 1 of the following, within 6 months of study entry:
  • Liver biopsy showing cirrhosis;
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  • Fibroscan showing cirrhosis or results >12.5 kPa;
  • FibroTest® score >0.75 and an aspartate aminotransferase (AST): platelet ratio index (APRI) >2 during screening.
  • Subjects must have the following laboratory parameters at screening:
  • ALT ≤ 10 x the upper limit of normal (ULN);
  • AST ≤ 10 x ULN;
  • Direct bilirubin ≤1.5 x ULN;
  • Platelets ≥ 50,000;
  • HbA1c ≤ 8.5%;
  • Creatinine clearance (CLcr) ≥ 60 mL /min, as calculated by the Cockcroft-Gault equation;
  • Hemoglobin ≥ 11 g/dL for female subjects; ≥ 12 g/dL for male subjects;
  • Albumin ≥ 3g/dL;
  • INR ≤ 1.5 x ULN unless subject has known hemophilia or is stable on an anticoagulant regimen affecting INR.
  • Subject has not been treated with any investigational drug or device within 30 days of the Screening visit.
  • A female subject is eligible to enter the study if it is confirmed that she is:
  • Not pregnant or nursing;
  • 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 (i.e., women who have not had a hysterectomy, both ovaries removed, or no medically documented ovarian failure) based on the following conditions.
  • 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 a negative urine pregnancy test on the Baseline/Day 0 visit prior to randomization. They must also agree to one of the following from 3 weeks prior to Baseline/Day 0 until 4 months after last dose of the triple/quadruple therapies:
  • Complete abstinence from intercourse. Periodic abstinence from intercourse (e.g., calendar, ovulation, symptothermal, post-ovulation methods) is not permitted.
  • Or
  • Consistent and correct use of 1 of the following methods of birth control listed below in addition to a male partner who correctly uses a condom from 3 weeks prior to Baseline/Day 0 until 4 months after last dose of the triple/quadruple therapies. Women of childbearing potential must not rely only on hormone-containing contraceptives as a form of birth control during the study. Female subjects using a hormone-containing contraceptive prior to Screening may continue their contraceptive regimen in addition to the study specified methods of birth control.
  • intrauterine device (IUD) with a failure rate of <1% per year
  • female barrier method: cervical cap or diaphragm with spermicidal agent
  • tubal sterilization
  • vasectomy in male partner
  • All male study participants must agree to consistently and correctly use a condom, while their female partner agrees to use either 1 of the non-hormonal methods of birth control listed above or a hormone-containing contraceptive listed below, from the date of Screening until 4 months after their last dose of the triple/quadruple therapies:
  • implants of levonorgestrel
  • injectable progesterone
  • oral contraceptives (either combined or progesterone only)
  • contraceptive vaginal ring
  • transdermal contraceptive patch
  • Male subjects must agree to refrain from sperm donation from the date of screening until at least 4 months after the last dose of the triple therapies.
  • Subject must be of generally good health, with the exception of chronic HCV infection, as determined by the Investigator.
  • Subject must be able to comply with the dosing instructions for study drug administration and able to complete the study schedule of assessments.
  • Screening ECG without clinically significant abnormalities.

Who cannot join

  • Child-Pugh scoring of B and C.
  • Creatinine Clearance < 30ml/min.
  • Mixed HCV genotypes.
  • Infection with hepatitis B virus (HBV) or human immunodeficiency virus (HIV).
  • Hepatocellular carcinoma or other malignancy (with exception of certain resolved skin cancers).
  • Current or prior history of any of the following:
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  • Clinically-significant illness (other than HCV) or any other major medical disorder that may interfere with subject treatment, assessment or compliance with the protocol; subjects currently under evaluation for a potentially clinically-significant illness (other than HCV) are also excluded.
  • Gastrointestinal disorder or post operative condition that could interfere with the absorption of the study drug.
  • Difficulty with blood collection and/or poor venous access for the purposes of phlebotomy.
  • Clinical hepatic decompensation (i.e., ascites, encephalopathy or variceal hemorrhage).
  • Solid organ transplantation.
  • Significant pulmonary disease, significant cardiac disease or porphyria.
  • Psychiatric hospitalization, suicide attempt, and/or a period of disability as a result of their psychiatric illness within the last 5 years. Subjects with psychiatric illness that is well-controlled on a stable treatment regimen for at least 12 months prior to randomization or has not required medication in the last 12 months may be included.
  • Malignancy diagnosed or treated within 5 years (recent localized treatment of squamous or non-invasive basal cell skin cancers is permitted; cervical carcinoma in situ is allowed if appropriately treated prior to screening); subjects under evaluation for malignancy are not eligible.
  • Significant drug allergy (such as anaphylaxis or hepatotoxicity).
  • History or current evidence of any condition, therapy, laboratory abnormality or other circumstance that might confound the results of the study, or interfere with the subject's participation for the full duration of the study, such that it is not in the best interest of the subject to participate
  • Pregnant or nursing female or male with pregnant female partner.
  • Chronic liver disease of a non-HCV etiology (e.g., hemochromatosis, Wilson's disease, alpha-1 antitrypsin deficiency, cholangitis).
  • Donation or loss of more than 400 mL blood within 2 months prior to Baseline/Day 1.
  • Clinically-relevant drug abuse within 12 months of screening. A positive drug screen will exclude subjects unless it can be explained by a prescribed medication; the diagnosis and prescription must be approved by the investigator.
  • Active or recent history (≤ 1 year) of drug or alcohol abuse.
  • Use of any following drugs that might interact with the study drugs.
  • Treatment with amiodarone within 180 days before study entry;
  • Treatment with digoxin within 30 days before study entry;
  • Treatment with rifabutin, rifampin, rifapentine, phenytoin, phenobarbital, St. John's wort, carbamazepine, oxcarbazepine, rosuvastatin, or atorvastatin within 10 days before study entry. However, switching to another statin is acceptable.
  • Screening or baseline electrocardiogram (ECG) with clinically significant findings.
  • QTcF (QT interval corrected using Fridericia's formula) > 450 msec at screening.
  • Chronic use of systemically administered immunosuppressive agents (e.g., prednisone equivalent > 10 mg/day).
  • Known hypersensitivity to sofosbuvir, daclatasvir, CDI-31244 and asunaprevir or formulation recipients.

Trial locations and contacts

1 site in 1 country.

Hong Kong1 site

  • Humanity & Health Research Centre

    Hong Kong, Hong Kong SAR

Other trials in Hong Kong

About this study

Official title: A Phase 2a, Open-label, Randomized Study of the Safety and Preliminary Efficacy of Triple or Quadruple Combination DAAs With Ultra-short Duration Therapy in Subjects With HCV Genotype 1b Infection (YANGTZE Study)

This is a phase 2a, open-label, randomized study. The study is designed to test the hypothesis that the nucleoside inhibitor sofosbuvir combined with NS5A inhibitor daclatasvir and NS5B non-nucleoside inhibitor CDI-31244 with/without the protease inhibitor asunaprevir will result in high SVR rate with a shortened treatment duration (2 weeks) in non-cirrhotic HCV genotype 1b-infected subjects.

Conditions
HCV Infection
Being tested
SOF+DCV+CDI-31244, SOF+DCV+CDI-31244+ASV
Medical subject headings
Hepatitis C

What participants receive

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

  • SOF+DCV+CDI-31244Drug

    Sofosbuvir (SOF) 400 mg administered orally once daily; Daclatasvir (DCV) 60 mg administered orally once daily; CDI-31244 400 mg administered orally once daily.

  • SOF+DCV+CDI-31244+ASVDrug

    Sofosbuvir (SOF) 400 mg administered orally once daily; Daclatasvir (DCV) 60 mg administered orally once daily; CDI-31244 400 mg orally once daily; Asunaprevir (ASV) 200mg administered orally twice daily.

Study groups in NCT03794258
Study groupRoleWhat they receive
SOF+DCV+CDI-31244ExperimentalSubjects will receive two weeks of sofosbuvir, daclatasvir, and CDI-31244 if they achieve HCV RNA < 500 IU/mL on Day 2 and HCV RNA < LLOQ (< 25 IU/mL) on Week 1.
Receives: Drug: SOF+DCV+CDI-31244
SOF+DCV+CDI-31244+ASVExperimentalSubjects will receive two weeks of sofosbuvir, daclatasvir, CDI-31244 and asunaprevir if they achieve HCV RNA < 500 IU/mL on Day 2 and HCV RNA < LLOQ (< 25 IU/mL) on Week 1.
Receives: Drug: SOF+DCV+CDI-31244+ASV

What is being measured

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

  1. Proportion of participants with sustained virologic response 12 weeks after discontinuation of therapy (SVR12)

    SVR12 is defined as HCV RNA < lower limit of quantification (LLOQ) 12 weeks after last dose of study drug.

    Measured: Post treatment Week 12

Secondary outcomes (4)

  1. Frequency and severity of adverse events

    Measured: Baseline up to Week 24

  2. Proportion of participants with unquantifiable HCV viral load at specified time points during and after treatment

    Measured: Baseline up to Week 24

  3. HCV RNA levels and change during and after treatment

    Measured: Baseline up to Week 24

  4. Proportion of participants with on-treatment virologic breakthrough and relapse

    Viral breakthrough is defined as having achieved undetectable HCV RNA levels (HCV RNA < LLOQ) during treatment, but did not achieve a sustained virologic response (SVR). Viral relapse is defined as having achieved undetectable HCV RNA levels (HCV RNA < LLOQ) within 4 weeks of end of treatment, but did not achieve an SVR.

    Measured: Baseline up to 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 posted7 Jan 2019
  2. Study start1 May 2019
  3. Primary completion15 Apr 2020
  4. Study completion30 Apr 2020

Why it stopped: Can not recruit the patients due to the pandemic of COVID-19

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
0 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03794258
Sponsor's protocol ID
H&H_YANGTZE_1
Status last verified
May 2020
First submitted
3 Jan 2019
Last updated
7 May 2020
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
Yes
FDA-regulated device
No

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing SOF+DCV+CDI-31244 and SOF+DCV+CDI-31244+ASV in people with HCV Infection, run by Humanity & Health Medical Group Limited at 1 site in Hong Kong.

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 41 inclusion and 29 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: withdrawn, as of the sponsor's last update on 7 May 2020. 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 Hong Kong. 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 was withdrawn before enrolling participants, so there are no results.

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?

Proportion of participants with sustained virologic response 12 weeks after discontinuation of therapy (SVR12) (time frame: Post treatment Week 12). 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 NCT03794258.

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 7 May 2020; AzTrials last refreshed its copy on 7 Nov 2026.

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