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Sofosbuvir Plus Ravidasvir for the Treatment of HCV Chronic Infection (STORM-C)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02961426
Recruitment Status : Recruiting
First Posted : November 11, 2016
Last Update Posted : February 5, 2020
Sponsor:
Collaborators:
Ministry of Health, Malaysia
Ministry of Health, Thailand
Information provided by (Responsible Party):
Drugs for Neglected Diseases

Brief Summary:
This is a Phase II/III, multicenter, multi-country, trial to assess the efficacy, safety, tolerance and pharmacokinetics of sofosbuvir plus ravidasvir for the treatment of HCV infection.

Condition or disease Intervention/treatment Phase
Hepatitis C Drug: sofosbuvir + ravidasvir Phase 2 Phase 3

Detailed Description:

This is a Phase II/III, multicenter, multi-country trial to assess the efficacy, safety, tolerance and pharmacokinetics of SOF-RDV for the treatment of HCV infection, across genotypes 1,2,3,6, among non-cirrhotic and cirrhotic with CTP class A, interferon/ribavirin naïve or experienced, HCV mono-infected and HCV/HIV co-infected subjects.

It will also study the pharmacokinetics of RDV and, in HCV/HIV co-infected subjects, possible drug-drug interactions with antiretrovirals.

The treatment duration will be 12 weeks for subjects with no cirrhosis (Metavir F0 to F3) and 24 weeks for subjects with compensated cirrhosis (Metavir F4, CTP class A).

The study is performed in 2 stages. Stage 1 has been completed. Efficacy and safety results from Stage 1 were reviewed and approved by the independent Data and Safety Monitoring Board (DSMB) which provided the recommendation to proceed with the study stage 2. On-going stage 2 aims to supplement Stage 1 results and provide additional information on the performance of SOF-RDV in the main genotypes found in Malaysia and Thailand.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 600 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Open Label Phase II/III, Multicenter, Trial to Assess the Efficacy, Safety, Tolerance, and Pharmacokinetics of Sofosbuvir Plus Ravidasvir in HCV (+/- HIV) Chronically Infected Adults With no or Compensated Cirrhosis in Thailand and Malaysia
Actual Study Start Date : September 2016
Estimated Primary Completion Date : March 2021
Estimated Study Completion Date : December 2023

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Hepatitis C
Drug Information available for: Sofosbuvir

Arm Intervention/treatment
Experimental: sofosbuvir + ravidasvir
12 weeks for non-cirrhotic patients, 24 weeks for cirrhotic patients
Drug: sofosbuvir + ravidasvir
combination of sofosbuvir + ravidasvir
Other Name: ravisdasvir: PPI-668




Primary Outcome Measures :
  1. Sustained Virological Response 12 weeks post treatment completion (SVR12), as evidenced by HCV RNA level less than the lower limit of quantification [ Time Frame: Outcome measure of sustained virological response will be assessed 12 weeks after the end of the treatment (SVR 12) as soon as the data will be available ]
    For patients with quantifiable HCV RNA during the post-treatment period, HCV sequences at baseline and at time of first quantifiable HCV RNA or as soon thereafter as possible will be compared to distinguish between relapses and reinfections.



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   18 Years to 70 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Evidence of chronic HCV infection, defined as: Positive anti-HCV antibody or detectable HCV RNA or HCV genotype at least 6 months before screening and HCV viral load ≥10^4 IU/mL at the time of screening / In subjects without documented HCV test results 6 months before screening, chronic hepatitis C infection can be assumed if risk exposures occurred > 6 months prior to screening and HCV viral load ≥10^4 IU/mL at the time of screening.
  • Willing and able to provide written informed consent.
  • Men and women age ≥ 18 years and < 70 years.
  • Body Mass Index (BMI) of 18 to 35 kg/m2.
  • Intention to comply with the dosing instructions for study drug administration and able to complete the study schedule of assessments.
  • Women with a negative pregnancy test at screening and baseline.
  • Women of child bearing potential who accept effective contraception from 2 weeks prior to study day 1 until 1 month post-treatment (Double contraceptive method including at least one barrier method). A woman is of non-child bearing potential if she (a)reached natural menopause determined retrospectively after 12 months of amenorrhea without any other obvious medical cause or (b)had procedures like bilateral tubal ligation or hysterectomy or bilateral oophorectomy.
  • Subjects who are compliant in an opioid substitution maintenance program (e.g. with methadone or buprenorphine) may be included as long as there is no concern about study medications adherence and interaction or compliance to study schedules. In stage 1, active injection drug users could also be enrolled, as a pre-stratified subpopulation, however their data did not contribute to the primary analysis.
  • Inclusion criteria related to HIV/HCV co-infected patients:

    • HIV/HCV co-infected patients receiving cART fulfilling the below criteria are eligible for the study: Antiretroviral therapy should have been initiated at least 6 months prior to screening / Patient has to have been on the same protocol-approved ARV regimen for ≥ 8 weeks prior to screening and is expected to continue the current ARV regimen through the end of study / HIV ARVs: agents allowed in this study should be administered per the prescribing information in the package insert / Screening HIV RNA < 50 copies/mL / Screening CD4 cell count ≥ 100 cells/uL
    • HIV/HCV co-infected patients not receiving cART: Screening CD4 cell count must be ≥ 500 cells/uL

Exclusion Criteria:

  • Decompensated cirrhosis defined as: Evidence of advanced stage liver cirrhosis and Child-Turcotte-Pugh (CTP) Class B or C or CTP score >6) or current/past history of decompensation including ascites, variceal bleeding, spontaneous bacterial peritonitis, or hepatic encephalopathy.
  • Hepatocellular carcinoma: for all patients with cirrhosis, hepatocellular carcinoma (HCC), should be excluded by liver imaging within 6 months prior to screening, and this must continue periodically as in routine HCC surveillance.
  • Laboratory exclusion criteria:

    • cirrhotic subjects with albumin < 2.8 g/dL
    • direct bilirubin > 3xULN
    • AST, ALT > 10xULN
    • Low neutrophil count (≤599 cells/mm3), hemoglobin (<9.0 g/dL for male, <8.5 g/dL for female), platelets (<50000 cells/mm3 ) classified as ≥ Grade 3
  • Patients with serum creatinine > 1.5 ULN or end stage renal disease
  • Hepatitis B co-infection (HBsAg positive)
  • Pregnancy, as documented by positive pregnancy tests at screening or baseline
  • Breastfeeding
  • Subjects currently receiving or unable to stop the use for at least 1 week prior to receiving the first dose of study drug any medications or herbal supplements known to be potent inhibitors or moderate inducers of cytochrome P450 (CYP) 3A4 or potent inducers of P-glycoprotein. This includes subjects who are on amiodarone or other contraindicated drugs.
  • Participation in other clinical trials within 3 months.
  • Any clinically significant findings or unstable condition during the screening, medical history or physical examination that, in the investigator's opinion, would compromise participation in this study. This could include patients with poorly controlled hypertension, asthma, diabetes, or other life-threatening conditions.
  • Current or history of use within the preceding 6 months of immunosuppressive or immune-modulating agents.
  • History of solid organ or bone marrow transplantation.
  • Any prior NS5A inhibitors therapy.
  • Patients with significant cardiovascular conditions including:

    • myocardial infarction within the previous 6 months or
    • heart failure NYHA class III or IV
    • history of Torsade de pointes
    • QTcF (Fridericia) value ≥ 450 milliseconds at Baseline
    • Severe sinus bradycardia with a rate of under 50 beats per minute
    • A sinus bradycardia with third degree atrioventricular block or with Mobitz II AV block
  • Use of medications associated with QT prolongation concurrently or within the 30 days prior to Screening Visit, including: macrolides, antiarrhythmic agents, azoles, fluoroquinolones, and tricyclic anti-depressants. Commonly used and essential medications for this study population like methadone and/or efavirenz is allowed as long as the QTcF value at baseline is < 450 milliseconds.
  • HIV/HCV co-infected patients not yet on stable antiretroviral therapy or for whom ART treatment initiation maybe scheduled during the study period.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02961426


Contacts
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Contact: Isabelle Andrieux-Meyer, MD +41 79 127 17 99 iandrieux-meyer@dndi.org
Contact: Caroline Menétrey +41 79 582 47 96 cmenetrey@dndi.org

Locations
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Malaysia
Hospital Raja Perempuan Zainab II Recruiting
Kota Bahru, Kelantan, Malaysia
Contact: Dato Dr. Mahiran Mustafa, MD         
Department of Hepatology, Hospital Selayang Recruiting
Batu Caves, Selangor, Malaysia, 68100
Contact: Haniza Omar, MD         
Department of Medicine/Gastroenterology, Hospital Sultanah Bahiyah Recruiting
Alor Setar, Malaysia
Contact: Datuk Dr Muhammad Radzi Bin Abu Hassan, MD         
Department of Medicine/ Gastroenterology, Hospital Ampang Recruiting
Ampang, Malaysia
Contact: Hajjah Rosaida Hj Mohd Said, MD         
Department of Medicine/Gastroenterology, University Malaya Medical Centre Completed
Kuala Lumpur, Malaysia
Hospital Tengku Ampuan Afzan ,Pusat Penyelidikan Klinikal,Aras Bawah ,Bangunan Pengurusan,Jalan Tanah Putih Completed
Kuantan, Malaysia
Department of Medicine/Infectious Disease, Hospital Sungai Buloh Recruiting
Sungai Buloh, Malaysia
Contact: Suresh Kumar Chindambaram Chindambaram, MD         
Thailand
King Chulalongkorn Memorial Hospital/HIV-NAT, Faculty of Medicine, Chulalongkorn University Recruiting
Bangkok, Thailand, 10330
Contact: Anchalee Avihingsanon, MD         
Internal Medicine, Bamrasnaradura Infectious Diseases Institute Recruiting
Bangkok, Thailand, 11000
Contact: Suparat Khemnark, MD         
Internal Medicine unit, Medical Department, Nakornping Hospital Recruiting
Chiang Mai, Thailand, 50180
Contact: Kanawee Thetket, MD         
Gastroenterology unit, Department of Internal Medicine, Maharaj Nakorn Chiang Mai Hospital, Faculty of Medicine, Chiang Mai University Recruiting
Chiang Mai, Thailand, 50200
Contact: Satawat Thongsawat, MD         
Sponsors and Collaborators
Drugs for Neglected Diseases
Ministry of Health, Malaysia
Ministry of Health, Thailand
Investigators
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Study Director: Isabelle Andrieux-Meyer, MD Drugs for Neglected Diseases
Principal Investigator: Soek-Siam Tan, MD Selayang Hospital
Principal Investigator: Satawat Thongsawat, MD Chiang Mai Hospital
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Responsible Party: Drugs for Neglected Diseases
ClinicalTrials.gov Identifier: NCT02961426    
Other Study ID Numbers: DNDi-SOF/RDV-01-HCV
First Posted: November 11, 2016    Key Record Dates
Last Update Posted: February 5, 2020
Last Verified: January 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Additional relevant MeSH terms:
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Hepatitis C
Hepatitis
Liver Diseases
Digestive System Diseases
Hepatitis, Viral, Human
Virus Diseases
Flaviviridae Infections
RNA Virus Infections
Sofosbuvir
Antiviral Agents
Anti-Infective Agents