NCT03020004

Brief 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.

Trial Health

100
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
70

participants targeted

Target at P50-P75 for phase_2

Timeline
Completed

Started Jan 2016

Shorter than P25 for phase_2

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2016

Completed
10 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 1, 2016

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

January 5, 2017

Completed
8 days until next milestone

First Posted

Study publicly available on registry

January 13, 2017

Completed
19 days until next milestone

Study Completion

Last participant's last visit for all outcomes

February 1, 2017

Completed
1 year until next milestone

Results Posted

Study results publicly available

February 7, 2018

Completed
Last Updated

July 26, 2018

Status Verified

January 1, 2017

Enrollment Period

10 months

First QC Date

January 5, 2017

Results QC Date

January 9, 2018

Last Update Submit

June 27, 2018

Conditions

Chronic Hepatitis C

Keywords

DanoprevirSVR12Chinese HCV G1non-cirrhotic

Outcome Measures

Primary Outcomes (1)

  • 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

    24 weeks

Study Arms (1)

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.

Drug: DanoprevirDrug: RitonavirDrug: peginterferon alfa-2aDrug: Ribavirin (RBV)

Interventions

DanoprevirDRUG

Danoprevir (DNV) 100mg tablet administered orally twice daily

Also known as: ASC08
Danoprevir,Ritonavir, Peg-IFN,RBV
RitonavirDRUG

Ritonavir 100mg tablet administered orally twice daily

Danoprevir,Ritonavir, Peg-IFN,RBV
peginterferon alfa-2aDRUG

PegIFN subcutaneous injection at 180 mcg weekly

Also known as: PegIFN
Danoprevir,Ritonavir, Peg-IFN,RBV
Ribavirin (RBV)DRUG

Ribavirin (RBV)1000/1200 mg/day (bodyweight\<75/≥75 kg)

Also known as: Ribasphere®
Danoprevir,Ritonavir, Peg-IFN,RBV

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Hepatitis C, Chronic

Interventions

danoprevirRitonavirpeginterferon alfa-2aRibavirin

Condition Hierarchy (Ancestors)

Hepatitis CBlood-Borne InfectionsCommunicable DiseasesInfectionsHepatitis, Viral, HumanVirus DiseasesFlaviviridae InfectionsRNA Virus InfectionsHepatitis, ChronicHepatitisLiver DiseasesDigestive System DiseasesChronic DiseaseDisease AttributesPathologic ProcessesPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

ThiazolesSulfur CompoundsOrganic ChemicalsAzolesHeterocyclic Compounds, 1-RingHeterocyclic CompoundsRibonucleosidesNucleosidesNucleic Acids, Nucleotides, and Nucleosides

Results Point of Contact

Title
Clinical Trial Disclosures
Organization
Ascletis Pharmaceuticals Co., Ltd
yicheng.zhao@ascletis.com
+86057185389732

Study Officials

  • Huoling Tang, PhD

    Ascletis Pharmaceuticals Co., Ltd.

    STUDY DIRECTOR

Publication Agreements

PI is Sponsor Employee
No
Restriction Type
OTHER
Restrictive Agreement
Yes

Study Design

Study Type
interventional
Phase
phase 2
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

January 5, 2017

First Posted

January 13, 2017

Study Start

January 1, 2016

Primary Completion

November 1, 2016

Study Completion

February 1, 2017

Last Updated

July 26, 2018

Results First Posted

February 7, 2018

Record last verified: 2017-01

Data Sharing

IPD Sharing
Will not share