Strategic Transformation of the Market of HCV Treatments

NCT02961426 | Unknown Phase 2

• 1 other identifier: DNDi-SOF/RDV-01-HCV
• Study Type: interventional
• Target: 603
• Locations: 2 countries
• Sites: 13

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.

Conditions

Hepatitis C

Outcome Measures

Primary Outcomes (1)

• Sustained Virological Response at 12 weeks post treatment completion (SVR12), as evidenced by HCV RNA level less than the lower limit of quantification

  Related objective: to assess the efficacy of sofosbuvir-ravidasvir (SOF-RDV) at 12 weeks after the end of study treatment

  12 weeks after the end of the study treatment

Secondary Outcomes (13)

• Sustained virologic response at 4 and 24 weeks post treatment completion (SVR4 and SVR24), as evidenced by HCV RNA level less than the lower limit of quantification

  4 and 24 weeks after the end of the study treatment

• Occurrence of on-treatment virologic failure among subjects not achieving SVR12

  12 weeks after the end of the study treatment

• Occurrence of virologic breakthrough among subjects not achieving SVR12

  12 weeks after the end of the study treatment

• Occurrence of virologic relapse among subjects not achieving SVR12

  12 weeks after the end of the study treatment

• Occurrence of non-virologic failure among subjects not achieving SVR12

  12 weeks after the end of the study treatment

Study Arms (1)

sofosbuvir + ravidasvir

EXPERIMENTAL

12 weeks for non-cirrhotic patients, 24 weeks for cirrhotic patients

Drug: sofosbuvir + ravidasvir

Interventions

sofosbuvir + ravidasvir DRUG

combination of sofosbuvir + ravidasvir

Also known as: ravisdasvir: PPI-668

sofosbuvir + ravidasvir

Eligibility Criteria

• Age: 18 Years - 69 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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 a highly effective contraceptive method from at least 2 weeks prior to study day 1 until 1-month post-treatment. 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.
• HIV/HCV co-infected patients receiving cART fulfilling the below criteria are eligible for the study: Antiretroviral therapy (ART) 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

You may not qualify if:

• 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.
• 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/excluded 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 as per standard guidelines and local practice. 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. Corticosteroid used to treat any medical condition are allowed if systemic for not more than 2 weeks or if topical.
• History of solid organ or bone marrow transplantation.

Sponsors & Collaborators

• Drugs for Neglected Diseases: lead
• Ministry of Health, Malaysia: collaborator
• Ministry of Health, Thailand: collaborator
• National Science and Technology Development Agency, Thailand: collaborator

Study Sites (13)

Hospital Sultanah Aminah

Johor Bahru, Johor, Malaysia

Location

Hospital Raja Perempuan Zainab II

Kota Bharu, Kelantan, Malaysia

Location

Department of Hepatology, Hospital Selayang

Batu Caves, Selangor, Malaysia

Location

Hospital Sultanah Nur Zahirah

Kuala Terengganu, Terengganu, Malaysia

Location

Department of Medicine/Gastroenterology, Hospital Sultanah Bahiyah

Alor Star, Malaysia

Location

Department of Medicine/ Gastroenterology, Hospital Ampang

Ampang, Malaysia

Location

Department of Medicine/Gastroenterology, University Malaya Medical Centre

Kuala Lumpur, Malaysia

Location

Hospital Tengku Ampuan Afzan ,Pusat Penyelidikan Klinikal,Aras Bawah ,Bangunan Pengurusan,Jalan Tanah Putih

Kuantan, Malaysia

Location

Department of Medicine/Infectious Disease, Hospital Sungai Buloh

Sungai Buloh, Malaysia

Location

King Chulalongkorn Memorial Hospital/HIV-NAT, Faculty of Medicine, Chulalongkorn University

Bangkok, 10330, Thailand

Location

Internal Medicine, Bamrasnaradura Infectious Diseases Institute

Bangkok, 11000, Thailand

Location

Internal Medicine unit, Medical Department, Nakornping Hospital

Chiang Mai, 50180, Thailand

Location

Gastroenterology unit, Department of Internal Medicine, Maharaj Nakorn Chiang Mai Hospital, Faculty of Medicine, Chiang Mai University

Chiang Mai, 50200, Thailand

Location

Related Publications (1)

• Andrieux-Meyer I, Tan SS, Thanprasertsuk S, Salvadori N, Menetrey C, Simon F, Cressey TR, Said HRHM, Hassan MRA, Omar H, Tee HP, Chan WK, Kumar S, Thongsawat S, Thetket K, Avihingsanon A, Khemnark S, Yerly S, Ngo-Giang-Huong N, Siva S, Swanson A, Goyal V, Bompart F, Pecoul B, Murad S. Efficacy and safety of ravidasvir plus sofosbuvir in patients with chronic hepatitis C infection without cirrhosis or with compensated cirrhosis (STORM-C-1): interim analysis of a two-stage, open-label, multicentre, single arm, phase 2/3 trial. Lancet Gastroenterol Hepatol. 2021 Jun;6(6):448-458. doi: 10.1016/S2468-1253(21)00031-5. Epub 2021 Apr 16.

  PMID: 33865507 DERIVED

MeSH Terms

Conditions

Hepatitis C

Interventions

Sofosbuvir; ravidasvir

Condition Hierarchy (Ancestors)

Blood-Borne Infections; Communicable Diseases; Infections; Hepatitis, Viral, Human; Virus Diseases; Flaviviridae Infections; RNA Virus Infections; Hepatitis; Liver Diseases; Digestive System Diseases

Intervention Hierarchy (Ancestors)

Uridine Monophosphate; Uracil Nucleotides; Pyrimidine Nucleotides; Pyrimidines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Nucleotides; Nucleic Acids, Nucleotides, and Nucleosides; Ribonucleotides

Study Officials

• Isabelle Andrieux-Meyer, MD

  Drugs for Neglected Diseases

  STUDY DIRECTOR

• Soek-Siam Tan, MD

  Selayang Hospital

  PRINCIPAL INVESTIGATOR

• Satawat Thongsawat, MD

  Chiang Mai Hospital

  PRINCIPAL INVESTIGATOR

Study Design

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

Study Record Dates

• First Submitted: September 7, 2016
• First Posted: November 11, 2016
• Study Start: September 1, 2016
• Primary Completion: August 1, 2021
• Study Completion: March 1, 2024
• Last Updated: January 20, 2021

Record last verified: 2021-01

Data Sharing

• IPD Sharing: Will not share

Locations

TH (4); MY (9)