Chronic Hepatitis CPhase 2NCT03020004

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

A Phase 2 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, Safety and Pharmacokinetics of Ritonavir-boosted Danoprevir (ASC08) 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: 70 participants
Where: No sites listed yet
Study dates: Jan 2016to Feb 2017
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 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) ;
Positive HCV antibody
Serum HCV RNA of ≥ 1 × 104 IU/mL
Hepatitis C virus GT1
Never received prior-treatment for HCV with interferon, RBV, or other direct-acting or host-targeting antivirals for HCV
The liver biopsy methods in the protocol (non-cirrhosis is defined as: Metavir score ˂ 4), or as determined by Fibroscan defined as: ˂ 14.6 kPa. Patients who have not obtained a liver biopsy or Fibroscan in the last 1 years will have a study related Fibroscan performed in order to confirm the diagnosis
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, including but not limited to, autoimmune hepatitis, α-1-antitrypsin deficiency, C282Y homozygous hemochromatosis, Wilson's disease, drug- or toxin-induced liver disease, alcohol-related liver disease, primary biliary cirrhosis, sclerosing cholangitis, and porphyria cutanea tarda causing liver pathology or requiring phlebotomy
Patients with a history of liver cell cancer, screening before or screening suspected hepatocellular carcinoma (HCC) patients, or imaging studies found suspicious nodules, or AFP > 50 ng/mL
Positive hepatitis A antibody，positive hepatitis B surface antigen，syphilis antibody or HIV antibody at screening
Others as specified in the detailed protocol

About this study

Official title: A Phase 2,Multicenter,Open-Label Study to Investigate the Efficacy, Safety and Pharmacokinetics of Ritonavir-boosted Danoprevir in Combination With Peg-IFN and RBV in Treatment-Naive Non-Cirrhotic Patients Who Have Chronic Hepatitis GT1

Conditions: Chronic Hepatitis C
Being tested: Danoprevir, Ritonavir, peginterferon alfa-2a, Ribavirin (RBV)
Keywords: Danoprevir, SVR12, Chinese HCV G1, non-cirrhotic
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) 100mg tablet administered orally twice daily
RitonavirDrug
Ritonavir 100mg tablet administered orally twice daily
peginterferon alfa-2aDrug
Also called PegIFN
PegIFN subcutaneous injection at 180 mcg weekly
Ribavirin (RBV)Drug
Also called Ribasphere®
Ribavirin (RBV)1000/1200 mg/day (bodyweight<75/≥75 kg)

Study groups in NCT03020004
Study group	Role	What they receive
Danoprevir,Ritonavir, Peg-IFN,RBV	Experimental	Participants will receive a combination of Ritonavir-boosted Danoprevir 100mg/100mg BID, subcutaneous injection of weekly peginterferon alfa-2a at 180 mcg and oral Ribavirin (RBV)1000/1200 mg/day (bodyweight<75/≥75 kg) for 12 weeks. Receives: Drug: Danoprevir; Drug: Ritonavir; Drug: peginterferon alfa-2a; Drug: Ribavirin (RBV)

What is being measured

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

Percentage of Subjects With Sustained Virologic Response (SVR12) 12 Weeks Post-treatment
SVR12, defined as undetectable HCV RNA 12 weeks after the last day of study drug administration
Measured: 24 weeks

Timeline

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

Jan 2016Feb 2017

First posted13 Jan 2017 (estimated)
Study startJan 2016
Primary completionNov 2016
Study completionFeb 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.
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 2
Primary purpose: Treatment
Allocation: Not applicable
Intervention model: Single group
Masking: None (open label)
Enrolment: 70 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT03020004
Sponsor's protocol ID: ASC08201502
Status last verified: Jan 2017
First submitted: 5 Jan 2017
Last updated: 26 Jul 2018
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: Yes
Individual data sharing: No

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 26 Jul 2018. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: A Phase 2,Multicenter,Open-Label Study to Investigate the Efficacy, Safety and Pharmacokinetics of Ritonavir-boosted Danoprevir in Combination With Peg-IFN and RBV in Treatment-Naive Non-Cirrhotic Patients Who Have Chronic Hepatitis GT1
ClinicalTrials.gov ID: NCT03020004
Acronym / sponsor ID: ASC08201502
Conditions: Chronic Hepatitis C
Keywords: Danoprevir, SVR12, Chinese HCV G1, non-cirrhotic
Phase: Phase 2
Study type: Interventional
Recruitment status: Completed
Enrolment: 70 participants (actual)
Lead sponsor: Ascletis Pharmaceuticals Co., Ltd.Industry (pharma, biotech, devices)
Study start: Jan 2016
Primary completion: Nov 2016 (actual)
Study completion: Feb 2017 (actual)
First posted: 13 Jan 2017 (estimated)
Results: Posted 7 Feb 2018

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: Ribavirin (RBV)Participants will receive a combination of Ritonavir-boosted Danoprevir 100mg/100mg BID, subcutaneous injection of weekly peginterferon alfa-2a at 180 mcg and oral Ribavirin (RBV)1000/1200 mg/day (bodyweight<75/≥75 kg) 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 (8 listed)

Willing and able to provide written informed consent
Chronic HCV infection (≥ 6 months) ;
Positive HCV antibody
Serum HCV RNA of ≥ 1 × 104 IU/mL
Hepatitis C virus GT1

Key exclusion criteria (5 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, including but not limited to, autoimmune hepatitis, α-1-antitrypsin deficiency, C282Y homozygous hemochromatosis, Wilson's disease, drug- or toxin-induced liver disease, alcohol-related liver disease, primary biliary cirrhosis, sclerosing cholangitis, and porphyria cutanea tarda causing liver pathology or requiring phlebotomy
Patients with a history of liver cell cancer, screening before or screening suspected hepatocellular carcinoma (HCC) patients, or imaging studies found suspicious nodules, or AFP > 50 ng/mL
Positive hepatitis A antibody，positive hepatitis B surface antigen，syphilis antibody or HIV antibody at screening
Others as specified in the detailed protocol

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) 100mg tablet administered orally twice daily	Drug	Danoprevir,Ritonavir, Peg-IFN,RBV
RitonavirRitonavir 100mg tablet administered orally twice daily	Drug	Danoprevir,Ritonavir, Peg-IFN,RBV
peginterferon alfa-2aAlso: PegIFNPegIFN subcutaneous injection at 180 mcg weekly	Drug	Danoprevir,Ritonavir, Peg-IFN,RBV
Ribavirin (RBV)Also: Ribasphere®Ribavirin (RBV)1000/1200 mg/day (bodyweight<75/≥75 kg)	Drug	Danoprevir,Ritonavir, Peg-IFN,RBV

Primary outcome

Percentage of Subjects With Sustained Virologic Response (SVR12) 12 Weeks Post-treatment
Time frame: 24 weeks
SVR12, defined as undetectable HCV RNA 12 weeks after the last day of study drug administration

Results and safety

Results posted to the registry on 7 Feb 2018, 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	70	69

Primary outcome: Percentage of Subjects With Sustained Virologic Response (SVR12) 12 Weeks Post-treatment

Time frame: 24 weeks. Count of participants. Unit: Participants

Measure	Danoprevir,Ritonavir, Peg-IFN,RBV n = 70
Value	66

Adverse events

Other adverse events reported at 5% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Danoprevir,Ritonavir, Peg-IFN,RBV	1 of 70 (1.4%)	70 of 70 (100%)	Not reported

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 26 Jul 2018.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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 2 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 8 inclusion and 5 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 26 Jul 2018. 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 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 7 Feb 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?

Percentage of Subjects With Sustained Virologic Response (SVR12) 12 Weeks Post-treatment (time frame: 24 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 NCT03020004.

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 26 Jul 2018.