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Hepatitis C, ChronicPhase 2NCT02340962

Evaluate the Efficacy and Safety of TG-2349 in Subjects With Hepatitis C Infection

A Phase 2 study testing TG-2349, Ribavirin and Interferon Alfa-2a in people with Hepatitis C, Chronic, run by TaiGen Biotechnology Co., Ltd. at 1 site in Taiwan.

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

A Phase 2, Multicenter, Randomized, Open-label, Dose-ranging Study to Evaluate the Efficacy and Safety of TG-2349 in Combination with Peg-interferon and Ribavirin in Treatment Naïve East Asian Subjects with Chronic Hepatitis C Virus Genotype 1b Infection. 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?
TG-2349, Ribavirin and Interferon Alfa-2a
Could I receive a placebo?
No, everyone receives an active treatment
How many people
25 participants
Where
1 siteTaiwan
Study dates
May 2015to 26 Oct 2016
Phase
Phase 2
Are there results?
Yes, posted in the registrySummary in the doctors' view

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.
  • East Asian subjects, male or female, and age between 18 (or legal adult age) and 70 years, inclusive, at Baseline/Day 1.
  • Body mass index (BMI) in the range of 18.0 to 35.0 kg/m2 (inclusive) and body weight ≥ 40 kg.
  • Presence of chronic hepatitis C (CHC) as documented below:
  • 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 (2) A liver biopsy or FibroTest performed prior to the Baseline/Day 1 visit with evidence of chronic HCV infection, such as the presence of fibrosis and/or inflammation.
  • 5. Positive for anti-HCV antibody at Screening. 6. Presence of an HCV RNA level ≥ 1 x 10000 IU/mL at Screening as determined by the Central Laboratory.
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  • 7. Presence of genotype 1b HCV-infection at Screening as determined by the Central Laboratory. Any non-definitive results will exclude the subject from study participation.
  • 8. HCV treatment naïve defined as no prior therapy with any interferon (IFN), ribavirin (RBV), or other approved or investigational HCV-specific agent.
  • 9. Absence of cirrhosis
  • Cirrhosis as defined as any one of the following:
  • Liver biopsy showing cirrhosis (e.g., Metavir score = 4 or Ishak score ≥ 5).
  • FibroScan showing cirrhosis or results > 12.5 kPa.
  • FibroTest fibrosis score of > 0.58 and APRI (AST: platelet ratio index) of > 2 during Screening.
  • If no definitive diagnosis of cirrhosis by the above criteria, a liver biopsy is required; liver biopsy results will supersede non-invasive testing results and be considered definitive.
  • 10. Screening ECG without clinically significant abnormalities. 11. Subjects must have the following laboratory parameters at Screening:
  • ALT ≤ 10 × the upper limit of normal (ULN)
  • AST ≤ 10 × ULN
  • Total bilirubin ≤ 1.5 × ULN except history of Gilbert's syndrome. If Gilbert's syndrome is the proposed etiology, the total bilirubin must ≤ 2 × ULN.
  • Absolute neutrophil count (ANC) ≥ 1,500 cells/mm3
  • Platelet count ≥ 90,000 cells/mm3
  • HbA1c ≤ 8.5%
  • Thyroid stimulating hormone (TSH) and free T4 ≤ ULN
  • Creatinine clearance (CLcr) ≥ 60 mL /min, as calculated by the Cockcroft-Gault equation
  • Serum creatinine ≤ 1.5 × ULN
  • Hemoglobin ≥ 11 g/dL for female subjects; ≥ 12 g/dL for male subjects
  • Albumin ≥ 3.5 g/dL
  • INR (International Normalized Ratio for Prothrombin Time) ≤ 1.5 x ULN unless subject is stable on an anticoagulant regimen affecting INR
  • Anti-nuclear antibodies (ANA) ≤ 1:320. 12. Subject must be of generally good health, with the exception of chronic HCV infection, as determined by Investigator.
  • 13. Subject must be able to comply with the dosing instructions for study drug administration and able to complete the study schedule of assessments, including all required Post-Treatment visits.
  • 14. A female subject is eligible to enter the study if it is confirmed that she is:
  • Not pregnant or nursing. (2) 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 (3) Of childbearing potential (i.e., women who have not had a hysterectomy, have not had both ovaries removed, and have not had medically documented ovarian failure).
  • 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 at the Baseline/Day 1 visit prior to randomization. They must also agree to one of the following from Screening until 6 months after the last dose of study drug(s):
  • 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 Screening until 6 months after the last dose of study drug(s):
  • 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
  • hormone-containing contraceptive:
  • implants of levonorgestrel ii. injectable progesterone iii. oral contraceptives (either combined or progesterone only) iv. contraceptive vaginal ring v. transdermal contraceptive patch. 15. Male subjects must agree to consistently and correctly use a condom, while their female partner agrees to use 1 of the methods of birth control listed above, from Screening until 6 months after the last dose of study drug(s).
  • 16. Male subjects must agree to refrain from sperm donation from Screening until at least 6 months after the last dose of study drug(s).

Who cannot join

  • Presence of cirrhosis.
  • Positive serological test for IgM anti-HAV (hepatitis A virus) antibody or HBsAg at Screening.
  • Positive ELISA test for HIV-1 or HIV-2 at Screening.
  • Chronic liver disease of a non-HCV etiology (e.g., hemochromatosis, Wilson disease, alfa-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 Investigator.
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  • Alcohol misuse as defined by an AUDIT score of ≥ 8.
  • Contraindications to RBV or IFN therapy, including hemoglobinopathies (e.g., thalassemia major or sickle-cell anemia), autoimmune thyroiditis or other autoimmune disorders including autoimmune hepatitis.
  • Pregnant or nursing female or male with pregnant female partner.
  • Use of any prohibited medications within 30 days of the Baseline/Day 1 visit:
  • Hematologic stimulating agents (e.g., erythropoiesis-stimulating agents [ESAs], granulocyte colony stimulating factor [G-CSF], and thrombopoietin [TPO] mimetics) (2) Chronic use of systemic immunosuppressants including, but not limited to, corticosteroids (prednisone equivalent of > 10 mg/day for > 2 weeks), azathioprine, or monoclonal antibodies (eg, infliximab) (3) Investigational agents or devices for any indication (4) Drugs disallowed per prescribing information of RBV or IFN (5) Any prohibited medications listed in Table 6-2. 11. Known hypersensitivity to RBV, IFN, TG-2349, sulfa drugs, or formulation excipients.
  • 12. Current or prior history of any of the following:
  • 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 drugs.
  • Difficulty with blood collection and/or poor venous access for the purposes of phlebotomy.
  • Clinical hepatic decompensation (i.e., ascites, encephalopathy or variceal hemorrhage).
  • Central nervous system (CNS) trauma, seizure disorder, stroke or transient ischemic attack.
  • Solid organ transplantation.
  • Significant cardiac disease (including but not limited to the myocardial infarction based on ECG and/or clinical history).
  • Significant pulmonary disease or porphyria.
  • Clinically significant retinal disease
  • 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 (without the prior mentioned conditions) that is well-controlled on a stable treatment regimen for at least 12 months prior to Baseline/Day 1 or has not required medication in the last 12 months may be included.
  • Malignancy within 5 years prior to Screening, with the exception of specific cancers that are entirely cured by surgical resection (basal cell skin cancer, etc). Subjects under evaluation for possible malignancy are not eligible.
  • Significant drug allergy (such as anaphylaxis or hepatotoxicity).

Trial locations and contacts

1 site in 1 country.

Taiwan1 site

  • Kaohsiung Medical University Chung-Ho Memorial Hospital

    Kaohsiung City

Other trials in Taiwan

About this study

Official title: Evaluate the Efficacy and Safety of TG-2349 in Combination With Peg-interferon and Ribavirin in Treatment naïve East Asian Subjects With Chronic Hepatitis C Virus Genotype 1b Infection.

A Phase 2, Multicenter, Randomized, Open-label, Dose-ranging Study to Evaluate the Efficacy and Safety of TG-2349 in Combination with Peg-interferon and Ribavirin in Treatment Naïve East Asian Subjects with Chronic Hepatitis C Virus Genotype 1b Infection.

Read the detailed description

It is a multicenter, randomized, open-label study to evaluate the safety, tolerability, and antiviral efficacy of two different doses of TG-2349 combined with Peg-interferon (IFN) and Ribavirin (RBV) in HCV-GT1b treatment naïve East Asian subjects. The treatment duration of TG-2349+IFN+RBV is 12 weeks, with or without an additional 12-week treatment of IFN+RBV, depending on HCV RNA level at On-Treatment Week 4. Approximately 24 subjects will be randomized (1:1) to one of the following 2 treatment groups:

  • Group I (n=12): 200 mg TG-2349 (2 capsules) + IFN + RBV
  • Group II (n=12): 400 mg TG-2349 (4 capsules) + IFN + RBV Randomization will be stratified by IL28B genotype "CC" or "non-CC". Subjects with HCV RNA < LLOQ (lower limit of quantification), TD (target detected) or TND (target not detected) at Week 4 will receive 12 weeks of TG-2349+IFN+RBV treatment. Subjects with HCV RNA ≥ LLOQ but < 100 IU/mL at Week 4 will receive 12 weeks of TG-2349+IFN+RBV treatment followed by an additional 12 weeks of IFN+RBV treatment. However, subjects with HCV RNA ≥ 100 IU/mL at Week 4 will discontinue the study treatment and complete the Early-Termination (ET) visit. The study will be terminated if 3 or more of the first 12 subjects enrolled across both Groups I and II, or ≥ 25% of subjects thereafter, fail to respond to treatment (i.e., confirmed on-treatment virologic failure or post-treatment relapse). Patients, except those who have achieved SVR12, will be offered the standard of care with Peg-interferon and Ribavirin for duration of 24, 48, or 72 weeks based on Taiwan's regulatory guideline and principal investigator's judgment.
Being tested
TG-2349, Ribavirin, Interferon Alfa-2a
Medical subject headings
Hepatitis C, Chronic

What participants receive

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

  • TG-2349Drug

    TG-2349 (Furaprevir) is available as a Swedish orange capsule (size 0) for oral administration. Each capsule contains an equivalent of 100 mg of TG-2349 spray dried solid (SDD) and the following inactive ingredients: microcrystalline cellulose, croscarmellose sodium, sodium lauryl sulfate, magnesium stearate, and colloidal silicon oxide.

  • RibavirinDrug

    RBV (Ribavirin or COPEGUS®) is available as a light pink to pink colored, flat, oval-shaped, film-coated tablet for oral administration. Each tablet contains 200 mg of ribavirin and the following inactive ingredients: pregelatinized starch, microcrystalline cellulose, sodium starch glycolate, cornstarch, and magnesium stearate. The coating of the tablet contains Chromatone-P® or Opadry® Pink (made by using hydroxypropyl methyl cellulose, talc, titanium dioxide, synthetic yellow iron oxide, and synthetic red iron oxide), ethyl cellulose (ECD-30), and triacetin.

  • Interferon Alfa-2aDrug

    IFN (Interferon, Peg-interferon alpha-2a or PEGASYS®) is available as a sterile, preservative-free, colorless to light yellow injectable solution administered subcutaneously.

    Each prefilled syringe of 180 μg/0.5 mL IFN (expressed as the amount of interferon alfa-2a) also contains acetic acid (0.0231 mg), benzyl alcohol (5 mg), polysorbate 80 (0.025 mg), sodium acetate trihydrate (1.3085 mg), and sodium chloride (4 mg) at pH 6 ± 0.5.

Study groups in NCT02340962
Study groupRoleWhat they receive
Group IExperimental200 mg TG-2349 (2 capsules) + Interferon or Peg-interferon + Ribavirin
Receives: Drug: TG-2349; Drug: Ribavirin; Drug: Interferon Alfa-2a
Group IIExperimental400 mg TG-2349 (4 capsules) + Interferon or Peg-interferon + Ribavirin
Receives: Drug: TG-2349; Drug: Ribavirin; Drug: Interferon Alfa-2a

What is being measured

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

  1. Proportion of Subjects Achieving Sustained Viral Response at 12 Weeks After the End of Treatment.

    Proportion of subjects with HCV RNA< LLOQ (lower limit of quantification), TD (target detected) or TND (target not detected) at 12 weeks after the end of treatment (SVR12) in the Full Analysis Set (FAS) population, which include subjects with genotype 1b HCV infection who were enrolled and received at least one dose of study drugs.

    Measured: 12 weeks after the end of treatment (SVR12), after 12-week treatments

Secondary outcomes (7)

  1. Proportion of Subjects Achieving Sustained Viral Response at 4, 8, and 24 Weeks After the End of Treatment (SVR4, SVR8, and SVR24)

    Measured: 4, 8, 24 weeks after the end of treatment (SVR4, 8, 24), after 12-week treatments

  2. Proportion of Subjects Achieving HCV RNA < Lower Limit of Quantification, Target Detected or Target Not Detected (< LLOQ, TD or TND)

    Measured: The whole treatment period, 12 weeks

  3. Proportion of Subjects Achieving HCV RNA < LLOQ, TND

    Measured: Treatment period (12 to 24 weeks) and after the end of treatment (12 to 24 weeks)

  4. Mean Absolute Values in HCV RNA (log10 IU/mL)

    Measured: Treatment period (12 to 24 weeks) and after the end of treatment (12 to 24 weeks)

  5. Proportion of Subjects Experiencing Virologic Failure During Treatment and Viral Relapse After the End of Treatment.

    Measured: Treatment period (12 to 24 weeks) and after the end of treatment (12 to 24 weeks)

  6. Proportion of Subjects With Abnormal Alanine Aminotransferase (ALT) Levels at Baseline Who Achieved Normal Limit of ALT at Final Treatment Visit.

    Measured: From baseline (day 1) to the final treatment visit (week 12 or week 24)

  7. Change From Baseline in HCV RNA (log10 IU/mL)

    Measured: Treatment period (12 to 24 weeks) and after the end of treatment (12 to 24 weeks)

Timeline

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

  1. First posted19 Jan 2015 (estimated)
  2. Study startMay 2015
  3. Primary completion12 Aug 2016
  4. Study completion26 Oct 2016

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
25 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02340962
Sponsor's protocol ID
TG-2349-03
Status last verified
Sep 2018
First submitted
8 Jan 2015
Last updated
14 Jul 2023
Data monitoring committee
Yes

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing TG-2349, Ribavirin and Interferon Alfa-2a in people with Hepatitis C, Chronic, run by TaiGen Biotechnology Co., Ltd. at 1 site in Taiwan.

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 24 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 14 Jul 2023. 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 Taiwan. 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?

Yes. Results are posted in the registry (first posted 12 Oct 2018). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

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 Subjects Achieving Sustained Viral Response at 12 Weeks After the End of Treatment. (time frame: 12 weeks after the end of treatment (SVR12), after 12-week treatments). 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 NCT02340962.

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 14 Jul 2023.

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