Chronic Hepatics C Virus (HCV) Genotype 1Phase 3NCT04155515
A Phase III Study to Evaluate Efficacy and Safety of TG-2349 in Combination With DAG181 and RBV for HCV Type I Patients
A Phase 3 study testing TG-2349, DAG181 and Ribavirin in people with Chronic Hepatics C Virus (HCV) Genotype 1 and Non-Cirrhotic, run by Dongguan HEC TaiGen Biopharmaceuticals Co., Ltd. at 1 site in China.
Trial summary
A Phase III, Multicenter, open-labeded study to Evaluate Efficacy and Safety of TG-2349 in Combination With DAG181 and Ribavirin for 12 weeks of treatment in HCV Genotype I Infected Patients Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Chronic Hepatics C Virus (HCV) Genotype 1, Non-Cirrhotic, Cirrhosis
- What is being tested?
- TG-2349, DAG181 and Ribavirin
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 370 participants
- Where
- 1 siteChina
- Study dates
- 13 Jun 2019to 11 Aug 2020
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Before starting the study, an informed consent form (ICF) approved by the Institutional Review Board (IRB) is obtained from the subject or his/her legal representative；
- Male or female, and ≥18 years of age inclusive when signing ICF；
- Body mass index (BMI) in the range of 18.0 to 35.0kg/m2 and body weight ≥ 40 kg at Screening；
- Presence of chronic hepatitis C (CHC) as documented below: (1)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 performed prior to the Baseline/Day 1 visit with evidence of chronic HCV infection；
- Positive for anti-HCV antibody at Screening；
- Presence of an HCV RNA level ≥ 1 x 10^4 IU/mL at Screening as determined by the Central Laboratory；
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- Presence of genotype 1a, 1b, or 1a/1b combination HCV-infection at Screening as determined by the Central Laboratory；
- HCV treatment naïve defined as no prior therapy with any interferon (IFN), ribavirin (RBV), or other approved or investigational HCV-specific agent；
- Without or with cirrhosis: (1) Without cirrhosis as defined as any one of the following: (a) Liver biopsy without showing cirrhosis (e.g., Metavir score < F4 or Ishak score < 5) within one year prior to Screening or at Screening. (b) FibroScan showing cirrhosis or results ≤ 12.5 kPa within six months prior to Screening or at Screening. (2) With cirrhosis as defined as any one of the following: (a) Liver biopsy showing cirrhosis (e.g., Metavir score = F4 or Ishak score ≥ 5) within one year prior to Screening or at Screening. (b) FibroScan showing cirrhosis or results > 12.5 kPa within six months prior to Screening or at Screening；NOTICE: If there is liver biopsy, liver biopsy results will supersede non-invasive testing results and be considered definitive.
- ECG without clinically significant abnormalities at Screening；
- Subjects must have the following laboratory parameters at Screening: (1) ALT ≤ 10 × the upper limit of normal (ULN). (2) AST ≤ 10 × ULN. (3) Without cirrhosis: 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. With cirrhosis: Total bilirubin ≤ 2 × ULN. (4) Platelet count ≥ 90,000 cells/mm3. (5) Absolute neutrophil count (ANC) ≥ 1,500 cells/mm3. (6) HbA1c ≤ 8.5%. (7) Creatinine clearance (CLcr) ≥ 50 mL /min, as calculated by the Cockcroft-Gault equation. (8) Hemoglobin ≥ 110 g/L for female subjects; ≥ 120 g/L for male subjects. (9) Without cirrhosis Albumin ≥ 3.5 g/dL；With cirrhosis Albumin ≥30g/L. (10) Without cirrhosis INR ≤ 1.5 x ULN；With cirrhosis INR ≤ 1.7 x ULN. (11) Alpha fetoprotein (AFP)<100 ng/mL；20ng/mL≤AFP≤100ng/mL need to take Liver Ultrasonic testing to exclude subjects with suspicious liver cancer cells. (12) Anti-nuclear antibodies (ANA) ≤ 1:320；
- A female subject is eligible to enter the study if it is confirmed that she is: (1) 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 (2) Of childbearing potential (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 agree to consistently and correctly use an approved contraceptive method (i.e. abstinence, vaginal ring, cervical cap, contraceptive diaphragm, or intrauterine devices) from screening until at least 6 months after the last dose of study drug(s)；
- Male subjects must agree to consistently and correctly use an approved contraceptive method (i.e. abstinence, condom, or spouses using contraceptive drugs, vaginal ring, cervical cap, contraceptive diaphragm, or intrauterine devices) from screening until at least 6 months after the last dose of study drug(s)；
- Male subjects must agree to refrain from sperm donation from screening until at least 6 months after the last dose of study drug(s)；
- Subject must be of generally good health, with the exception of chronic HCV infection, as determined by Investigator；
- 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.
Who cannot join
- Positive serological test for IgM anti-HAV or anti-HEV antibody at Screening；
- Positive serological test for HBsAg at Screening；
- Positive test for HIV-1 or HIV-2 at Screening；
- Clinically-relevant drug abuse within 12 months of signing the ICF. 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；
- Alcohol misuse as defined by an AUDIT score of ≥ 8；
- Contraindications to RBV therapy, including hemoglobinopathies (e.g., thalassemia major or sickle-cell anemia)；
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- Pregnant or nursing female or male with pregnant female partner；
- Use of any prohibited medications before Baseline/Day 1 visit；
- Known hypersensitivity to TG-2349, DAG181, RBV, sulfa drugs, or formulation excipients；
- Current or prior history of any of the following: (1) Chronic hepatic disorder not induced by HCV (including but not limited to Hemochromatosis, Wilson's disease, alpha-1 antitrypsin deficiency, cholangitis, autoimmune hepatitis, alcoholic liver disease, drug-induced liver disease. (2) Decompensated liver cirrhosis (Child-Pugh class B and C). (3) Any dysphagia, malabsorption syndrome, or other gastrointestinal disturbances affecting drug absorption. (4) Difficulty with blood collection and/or poor venous access for the purposes of phlebotomy. (5) Central nervous system (CNS) trauma, seizure disorder, stroke or transient ischemic attack. (6) Solid organ transplantation. (7) Significant cardiac disease (including but not limited to the myocardial infarction based on ECG and/or clinical history). (8) Significant pulmonary disease or porphyria (e.g. lung infiltration or impaired lung function). (9) Pancreatitis. (10) Autoimmune disease (systemic lupus erythematosus, rheumatoid arthritis, sarcoidosis, psoriasis). (11) Psychiatric hospitalization, suicide attempt, and/or a period of disability as a result of their psychiatric illness within the last 5 years. (12) 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. (13) Serious acute drug allergy (such as anaphylaxis or hepatotoxicity) or serious skin hypersensitive reaction (such as vesicular rash, Stevens Johnson Syndrome)；
- As determined by Investigator, a subject that would affect the therapy, evaluation or compliance with the protocol is not suitable to take part in this study.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Phase III, Multicenter, Open-labeded Study To Evaluate Efficacy and Safety of TG-2349 in Combination With DAG181 and Ribavirin for 12 Weeks of Treatment in HCV Genotype I Infected Patients
A Phase III, Multicenter, open-labeded study to Evaluate Efficacy and Safety of TG-2349 in Combination With DAG181 and Ribavirin for 12 weeks of treatment in HCV Genotype I Infected Patients
Read the detailed description
The purpose of this study is to evaluate efficacy and safety of TG-2349 in combination with DAG181 and Ribavirin for 12 weeks of treatment in HCV Genotype I infected patients. Approximately 360 subjects will be enrolled in this study and divided into 2 groups:
Group 1: Chronic hepatics C virus (HCV) genotype 1 infected, non-cirrhotic subjects.
Group 2: Chronic hepatics C virus (HCV) genotype 1 infected, cirrhotic subjects.
- Being tested
- TG-2349, DAG181, Ribavirin
- Keywords
- Chronic Hepatics C Virus (HCV) Genotype 1, Non-Cirrhotic, Cirrhosis, Treatment naïve, efficacy, safety, TG-2349, DAG181, Ribavirin
- Medical subject headings
- Hepatitis C, Fibrosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
TG-2349Drug
TG-2349 400mg
DAG181Drug
DAG181 200mg
RibavirinDrug
Ribavirin 1000mg/1200mg
| Study group | Role | What they receive |
|---|---|---|
| Non-cirrhotic, HCV genotype 1 infected subjects | Other | Subjects will be treated with TG-2349 400mg combined with DAG181 200mg and Ribaverin 1000mg/1200mg for 12 weeks. Receives: Drug: TG-2349; Drug: DAG181; Drug: Ribavirin |
| Cirrhotic, HCV genotype 1 infected subjects | Other | Subjects will be treated with TG-2349 400mg combined with DAG181 200mg and Ribaverin 1000mg/1200mg for 12 weeks. Receives: Drug: TG-2349; Drug: DAG181; Drug: Ribavirin |
What is being measured
The primary outcome is the main question the study is designed to answer.
The proportion of antiviral efficacy (HCV RNA < lower limit of quantification, target detected or target not detected) at 12 weeks after the end of treatment
To evaluate the antiviral efficacy
Measured: 12 weeks after the end of treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Nov 2019
- Study start13 Jun 2019
- Primary completion11 Aug 2020
- Study completion11 Aug 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Chronic Hepatics C Virus (HCV) Genotype 1Studies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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
- Non-randomised
- Intervention model
- Parallel groups
- Model description
- The non-cirrhotic, HCV genotype 1 infected subjects will be assigned to Group 1. The cirrhotic, HCV genotype 1 infected subjects will be assigned to Group 2. The subjects in Group 1 and 2 will be treated with TG-2349 400mg combined with DAG181 200mg and Ribaverin 1000mg/1200mg for 12 weeks.
- Masking
- None (open label)
- Enrolment
- 370 participants (actual)
Sponsor and investigators
- Lead sponsor
- Dongguan HEC TaiGen Biopharmaceuticals Co., Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04155515
- Sponsor's protocol ID
- TGDAG-C-3
- Status last verified
- Jan 2021
- First submitted
- 5 Nov 2019
- Last updated
- 4 Feb 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 4 Feb 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase III, Multicenter, Open-labeded Study To Evaluate Efficacy and Safety of TG-2349 in Combination With DAG181 and Ribavirin for 12 Weeks of Treatment in HCV Genotype I Infected Patients
- ClinicalTrials.gov ID
- NCT04155515
- Acronym / sponsor ID
- TGDAG-C-3
- Keywords
- Chronic Hepatics C Virus (HCV) Genotype 1, Non-Cirrhotic, Cirrhosis, Treatment naïve, efficacy, safety, TG-2349, DAG181
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 370 participants (actual)
- Lead sponsor
- Dongguan HEC TaiGen Biopharmaceuticals Co., Ltd.Industry (pharma, biotech, devices)
- Study start
- 13 Jun 2019 (actual)
- Primary completion
- 11 Aug 2020 (actual)
- Study completion
- 11 Aug 2020 (actual)
- First posted
- 7 Nov 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
A Phase III, Multicenter, open-labeded study to Evaluate Efficacy and Safety of TG-2349 in Combination With DAG181 and Ribavirin for 12 weeks of treatment in HCV Genotype I Infected Patients
Detailed description
The purpose of this study is to evaluate efficacy and safety of TG-2349 in combination with DAG181 and Ribavirin for 12 weeks of treatment in HCV Genotype I infected patients. Approximately 360 subjects will be enrolled in this study and divided into 2 groups:
Group 1: Chronic hepatics C virus (HCV) genotype 1 infected, non-cirrhotic subjects.
Group 2: Chronic hepatics C virus (HCV) genotype 1 infected, cirrhotic subjects.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- The non-cirrhotic, HCV genotype 1 infected subjects will be assigned to Group 1. The cirrhotic, HCV genotype 1 infected subjects will be assigned to Group 2. The subjects in Group 1 and 2 will be treated with TG-2349 400mg combined with DAG181 200mg and Ribaverin 1000mg/1200mg for 12 weeks.
| Arm | Type | Receives |
|---|---|---|
| Non-cirrhotic, HCV genotype 1 infected subjects | Other | Drug: TG-2349, Drug: DAG181, Drug: RibavirinSubjects will be treated with TG-2349 400mg combined with DAG181 200mg and Ribaverin 1000mg/1200mg for 12 weeks. |
| Cirrhotic, HCV genotype 1 infected subjects | Other | Drug: TG-2349, Drug: DAG181, Drug: RibavirinSubjects will be treated with TG-2349 400mg combined with DAG181 200mg and Ribaverin 1000mg/1200mg for 12 weeks. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (16 listed)
- Before starting the study, an informed consent form (ICF) approved by the Institutional Review Board (IRB) is obtained from the subject or his/her legal representative；
- Male or female, and ≥18 years of age inclusive when signing ICF；
- Body mass index (BMI) in the range of 18.0 to 35.0kg/m2 and body weight ≥ 40 kg at Screening；
- Presence of chronic hepatitis C (CHC) as documented below: (1)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 performed prior to the Baseline/Day 1 visit with evidence of chronic HCV infection；
- Positive for anti-HCV antibody at Screening；
Key exclusion criteria (11 listed)
- Positive serological test for IgM anti-HAV or anti-HEV antibody at Screening；
- Positive serological test for HBsAg at Screening；
- Positive test for HIV-1 or HIV-2 at Screening；
- Clinically-relevant drug abuse within 12 months of signing the ICF. 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；
- Alcohol misuse as defined by an AUDIT score of ≥ 8；
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| TG-2349TG-2349 400mg | Drug | Cirrhotic, HCV genotype 1 infected subjects, Non-cirrhotic, HCV genotype 1 infected subjects |
| DAG181DAG181 200mg | Drug | Cirrhotic, HCV genotype 1 infected subjects, Non-cirrhotic, HCV genotype 1 infected subjects |
| RibavirinRibavirin 1000mg/1200mg | Drug | Cirrhotic, HCV genotype 1 infected subjects, Non-cirrhotic, HCV genotype 1 infected subjects |
Primary outcome
The proportion of antiviral efficacy (HCV RNA < lower limit of quantification, target detected or target not detected) at 12 weeks after the end of treatment
Time frame: 12 weeks after the end of treatment
To evaluate the antiviral efficacy
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Feb 2021.
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing TG-2349, DAG181 and Ribavirin in people with Chronic Hepatics C Virus (HCV) Genotype 1 and Non-Cirrhotic, run by Dongguan HEC TaiGen Biopharmaceuticals 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 16 inclusion and 11 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 4 Feb 2021. 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 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?
The proportion of antiviral efficacy (HCV RNA < lower limit of quantification, target detected or target not detected) at 12 weeks after the end of treatment (time frame: 12 weeks after the end of treatment). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 4 Feb 2021.