Chronic Hepatitis CPhase 3NCT03020082

Efficacy and Safety of Danoprevir/r + PR 12week Triple Therapy in Treatment Naive Non-Cirrhotic G1 CHC China III

A Phase 3 study testing Danoprevir, Ritonavir and peginterferon alfa-2a in people with Chronic Hepatitis C, run by Ascletis Pharmaceuticals Co., Ltd..

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

The purpose of this study is to evaluate the efficacy and safety of Ritonavir-boosted ASC08 (Danoprevir) in Combination with Peg-IFN and RBV in Treatment-Naive Non-Cirrhotic Patients Who Have Chronic Hepatitis Genotype 1. Read more about this study

Who is it for?: Ages 18 years and older
Conditions the study is for: Chronic Hepatitis C
What is being tested?: Danoprevir, Ritonavir and peginterferon alfa-2a
Type of treatment: Pill or oral medicine, Injection or infusion
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 141 participants
Where: No sites listed yet
Study dates: Jun 2016to May 2017
Phase: Phase 3
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 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
Chronic HCV infection (≥ 6 months)
Serum HCV RNA of ≥ 1 × 104 IU/mL are documented
Hepatitis C virus GT1
Never received prior-treatment for HCV with interferon, RBV, or other direct-acting or host-targeting antivirals for HCV
Non-cirrhosis patients: Non-cirrhosis is defined (1)Fibroscan defined as: ˂ 14.6 kPa during screening period, or liver biopsy determined 1 year before recruiting (Metavir score ˂ 3);(2) during screening period 9.6<Fibroscan indicator ≤12.9, liver biopsy need to confirm non-cirrhosis.
Others as specified in the detailed protocol

Who cannot join

Patients with Fibroscan detection value > 12.9 kPa, or histologic examination for liver cirrhosis patients
Presence or history of non-hepatitis C chronic liver disease (e.g. HH, AIH, Wilson's disease, α1 antitrypsin deficiency, drug- or toxin-induced liver disease)
History of liver cell cancer, or suspected hepatocellular carcinoma (HCC) patients before or during screening , or imaging studies found suspicious nodules, or AFP > 50 ng/mL
Positive hepatitis A antibody，positive hepatitis B surface antigen，HIV antibody
Presence or history of nervous system diseases and/or mental illness, inability to control oneself or express oneself.
Patients with obvious cardiovascular dysfunction
Pregnant or nursing female, nor unwilling to take reliable contraception
Others as specified in the detailed protocol

About this study

Official title: A Multi-centered, Open Label, Phase III Study on Efficacy, Safety of Ritonavir-boosted ASC08 (Danoprevir) in Combination With Peg-IFN and RBV in Treatment-Naive Non-Cirrhotic Patients Who Have Chronic Hepatitis Genotype 1

Conditions: Chronic Hepatitis C
Being tested: Danoprevir, Ritonavir, peginterferon alfa-2a, RBV
Keywords: Danoprevir, non-cirrhotic, Chinese HCV G1, SVR12
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.

DanoprevirDrug
Also called ASC08
Danoprevir (DNV)administered orally 100mg BID for 12 weeks;
RitonavirDrug
Ritonavir administered orally 100mg BID for 12 weeks;
peginterferon alfa-2aDrug
Also called Peg-IFN
PEG-IFN abdominal or thigh subcutaneous injection, 180μg, once a week for 12 weeks;
RBVDrug
Also called Ribasphere®
RBV administered orally 500mg (5 tablets)( body weight <75Kg) BID, 600mg (6 tablets) BID body weight ≥75Kg, for 12 weeks.

Study groups in NCT03020082
Study group	Role	What they receive
Danoprevir, Ritonavir, Peg-IFN,RBV	Experimental	Participants will receive Ritonavir- boosted Danoprevir 100mg/100mg BID in combination with subcutaneous injection of weekly peginterferon alfa-2a at 180 mcg and RBV administered orally 500mg (5 tablets)( body weight <75Kg) BID, 600mg (6 tablets) BID body weight ≥75Kg for 12 weeks. Receives: Drug: Danoprevir; Drug: Ritonavir; Drug: peginterferon alfa-2a; Drug: RBV

What is being measured

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

Proportion of Participants With Sustained Virologic Response 12 Weeks After Discontinuation of Therapy (SVR12)
Measured: 12 weeks

Timeline

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

Jun 2016May 2017

First posted13 Jan 2017 (estimated)
Study startJun 2016
Primary completionMay 2017
Study completionMay 2017

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Publications (1)Papers the sponsor has linked to this study.
Other trials for Chronic Hepatitis CStudies 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: Not applicable
Intervention model: Single group
Masking: None (open label)
Enrolment: 141 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT03020082
Sponsor's protocol ID: ASC08201503
Status last verified: Jan 2017
First submitted: 5 Jan 2017
Last updated: 23 Mar 2021
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: Yes
Individual data sharing: No

Publications

Wei L, Shang J, Ma Y, Xu X, Huang Y, Guan Y, Duan Z, Zhang W, Gao Z, Zhang M, Li J, Jia J, Yang Y, Wen X, Wang M, Jia Z, Ning B, Chen Y, Qi Y, Du J, Jiang J, Tong L, Xie Y, Wu JJ. Efficacy and Safety of 12-week Interferon-based Danoprevir Regimen in Patients with Genotype 1 Chronic Hepatitis C. J Clin Transl Hepatol. 2019 Sep 28;7(3):221-225. doi: 10.14218/JCTH.2019.00018. Epub 2019 Jul 22.
PubMed 31608213

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

Official record

RecruitingObservational study
Evaluation of Patients With Liver Disease
Hepatitis D, Hepatitis C
Active, not recruitingPhase 4
People With CHC Who Achieved a Sustained Virological Response Following Therapy With Direct Acting Antiviral Agents
Diabetes Mellitus, Hepatitis C, Chronic
RecruitingObservational study
"Constitution of a Biological Collection to Establish Preclinical Translational Models for the Study of Tumors and Chronic Liver Diseases".
Chronic Liver Disease and Cirrhosis, Liver Cancer
Active, not recruitingPhase 4
Sofosbuvir/Velpatasvir Treatment of Chronic Hepatitis C During Pregnancy
Hepatitis C, Chronic, Pregnancy; Infection
Enrolling by invitationObservational study
Comparative Autoantibody and Immunologic Cell Marker Study
Autoimmune Diseases, Lupus Erythematosus, Systemic

All Chronic Hepatitis C trials

Study at a glance

From the registry record, last updated by the sponsor on 23 Mar 2021. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: A Multi-centered, Open Label, Phase III Study on Efficacy, Safety of Ritonavir-boosted ASC08 (Danoprevir) in Combination With Peg-IFN and RBV in Treatment-Naive Non-Cirrhotic Patients Who Have Chronic Hepatitis Genotype 1
ClinicalTrials.gov ID: NCT03020082
Acronym / sponsor ID: ASC08201503
Conditions: Chronic Hepatitis C
Keywords: Danoprevir, non-cirrhotic, Chinese HCV G1, SVR12
Phase: Phase 3
Study type: Interventional
Recruitment status: Completed
Enrolment: 141 participants (actual)
Lead sponsor: Ascletis Pharmaceuticals Co., Ltd.Industry (pharma, biotech, devices)
Study start: Jun 2016
Primary completion: May 2017 (actual)
Study completion: May 2017 (actual)
First posted: 13 Jan 2017 (estimated)
Results: Posted 23 Mar 2021

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Study design

Primary purpose: Treatment
Allocation: Not applicable
Intervention model: Single group
Masking: None (open label)
Number of arms: 1

Arm	Type	Receives
Danoprevir, Ritonavir, Peg-IFN,RBV	Experimental	Drug: Danoprevir, Drug: Ritonavir, Drug: peginterferon alfa-2a, Drug: RBVParticipants will receive Ritonavir- boosted Danoprevir 100mg/100mg BID in combination with subcutaneous injection of weekly peginterferon alfa-2a at 180 mcg and RBV administered orally 500mg (5 tablets)( body weight <75Kg) BID, 600mg (6 tablets) BID body weight ≥75Kg 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 (7 listed)

Willing and able to provide written informed consent
Chronic HCV infection (≥ 6 months)
Serum HCV RNA of ≥ 1 × 104 IU/mL are documented
Hepatitis C virus GT1
Never received prior-treatment for HCV with interferon, RBV, or other direct-acting or host-targeting antivirals for HCV

Key exclusion criteria (8 listed)

Patients with Fibroscan detection value > 12.9 kPa, or histologic examination for liver cirrhosis patients
Presence or history of non-hepatitis C chronic liver disease (e.g. HH, AIH, Wilson's disease, α1 antitrypsin deficiency, drug- or toxin-induced liver disease)
History of liver cell cancer, or suspected hepatocellular carcinoma (HCC) patients before or during screening , or imaging studies found suspicious nodules, or AFP > 50 ng/mL
Positive hepatitis A antibody，positive hepatitis B surface antigen，HIV antibody
Presence or history of nervous system diseases and/or mental illness, inability to control oneself or express oneself.

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
DanoprevirAlso: ASC08Danoprevir (DNV)administered orally 100mg BID for 12 weeks;	Drug	Danoprevir, Ritonavir, Peg-IFN,RBV
RitonavirRitonavir administered orally 100mg BID for 12 weeks;	Drug	Danoprevir, Ritonavir, Peg-IFN,RBV
peginterferon alfa-2aAlso: Peg-IFNPEG-IFN abdominal or thigh subcutaneous injection, 180μg, once a week for 12 weeks;	Drug	Danoprevir, Ritonavir, Peg-IFN,RBV
RBVAlso: Ribasphere®RBV administered orally 500mg (5 tablets)( body weight <75Kg) BID, 600mg (6 tablets) BID body weight ≥75Kg, for 12 weeks.	Drug	Danoprevir, Ritonavir, Peg-IFN,RBV

Primary outcome

Proportion of Participants With Sustained Virologic Response 12 Weeks After Discontinuation of Therapy (SVR12)
Time frame: 12 weeks

Results and safety

Results posted to the registry on 23 Mar 2021, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Danoprevir, Ritonavir, Peg-IFN,RBV	141	138

Primary outcome: Proportion of Participants With Sustained Virologic Response 12 Weeks After Discontinuation of Therapy (SVR12)

Time frame: 12 weeks. Count of participants. Unit: Participants

Measure	Danoprevir, Ritonavir, Peg-IFN,RBV n = 141
Value	136

Adverse events

Time frame: 24 weeks. Other adverse events reported at 5% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Danoprevir, Ritonavir, Peg-IFN,RBV	5 of 141 (3.5%)	76 of 141 (53.9%)	0 of 141

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 23 Mar 2021.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Derived from this study: PubMed 31608213Wei L, Shang J, Ma Y, Xu X, Huang Y, Guan Y, Duan Z, Zhang W, Gao Z, Zhang M, Li J, Jia J, Yang Y, Wen X, Wang M, Jia Z, Ning B, Chen Y, Qi Y, Du J, Jiang J, Tong L, Xie Y, Wu JJ. Efficacy and Safety of 12-week Interferon-based Danoprevir Regimen in Patients with Genotype 1 Chronic Hepatitis C. J Clin Transl Hepatol. 2019 Sep 28;7(3):221-225. doi: 10.14218/JCTH.2019.00018. Epub 2019 Jul 22.
Individual participant dataSharing planned: No

Related trials for Chronic Hepatitis C

RecruitingObservational study
Evaluation of Patients With Liver Disease
Hepatitis D, Hepatitis C
Active, not recruitingPhase 4
People With CHC Who Achieved a Sustained Virological Response Following Therapy With Direct Acting Antiviral Agents
Diabetes Mellitus, Hepatitis C, Chronic
RecruitingObservational study
"Constitution of a Biological Collection to Establish Preclinical Translational Models for the Study of Tumors and Chronic Liver Diseases".
Chronic Liver Disease and Cirrhosis, Liver Cancer
Active, not recruitingPhase 4
Sofosbuvir/Velpatasvir Treatment of Chronic Hepatitis C During Pregnancy
Hepatitis C, Chronic, Pregnancy; Infection
Enrolling by invitationObservational study
Comparative Autoantibody and Immunologic Cell Marker Study
Autoimmune Diseases, Lupus Erythematosus, Systemic

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.

Huoling Tang, PhD study director

Ascletis Pharmaceuticals Co., Ltd.

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing Danoprevir, Ritonavir and peginterferon alfa-2a in people with Chronic Hepatitis C, run by Ascletis Pharmaceuticals Co., Ltd..

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 7 inclusion and 8 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 23 Mar 2021. Status can change between updates, so confirm with the study contact before making plans.

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?

Yes. Results are posted in the registry (first posted 23 Mar 2021). 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 Participants With Sustained Virologic Response 12 Weeks After Discontinuation of Therapy (SVR12) (time frame: 12 weeks). 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 NCT03020082, 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 23 Mar 2021.