Hepatitis CPhase 2/3STORM-C-1NCT02961426
Strategic Transformation of the Market of HCV Treatments
A Phase 2/3 study testing sofosbuvir + ravidasvir in people with Hepatitis C, run by Drugs for Neglected Diseases at 13 sites in 2 countries.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 69 years
- Conditions the study is for
- Hepatitis C
- What is being tested?
- sofosbuvir + ravidasvir
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 603 participants
- Where
- 13 sitesin 2 countries
- Study dates
- Sep 2016to Mar 2024
- Phase
- Phase 2/3
- Are there results?
- None posted in the registry
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 to 69 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
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- 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.
- 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 (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
Who cannot join
- 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
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- 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.
- 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
- Third degree heart block
- 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.
- Self-reporting active injection drug use at screening (only for stage 2).
- Exclusion criteria related to HIV/HCV co-infected patients: HIV/HCV co-infected patients not yet on stable antiretroviral therapy or for whom ART treatment initiation maybe scheduled during the study period.
Trial locations and contacts
13 sites in 2 countries.
13 sites in 2 countries
Malaysia9 sites
Department of Medicine/Gastroenterology, Hospital Sultanah Bahiyah
Alor Star
Department of Medicine/ Gastroenterology, Hospital Ampang
Ampang
Department of Hepatology, Hospital Selayang
Batu Caves, Selangor
Hospital Sultanah Aminah
Johor Bahru, Johor
Hospital Raja Perempuan Zainab II
Kota Bharu, Kelantan
Department of Medicine/Gastroenterology, University Malaya Medical Centre
Kuala Lumpur
Hospital Sultanah Nur Zahirah
Kuala Terengganu, Terengganu
Hospital Tengku Ampuan Afzan ,Pusat Penyelidikan Klinikal,Aras Bawah ,Bangunan Pengurusan,Jalan Tanah Putih
Kuantan
Department of Medicine/Infectious Disease, Hospital Sungai Buloh
Sungai Buloh
Thailand4 sites
King Chulalongkorn Memorial Hospital/HIV-NAT, Faculty of Medicine, Chulalongkorn University
Bangkok, 10330
Internal Medicine, Bamrasnaradura Infectious Diseases Institute
Bangkok, 11000
Internal Medicine unit, Medical Department, Nakornping Hospital
Chiang Mai, 50180
Gastroenterology unit, Department of Internal Medicine, Maharaj Nakorn Chiang Mai Hospital, Faculty of Medicine, Chiang Mai University
Chiang Mai, 50200
About this study
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
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.
Read the 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.
- Conditions
- Hepatitis C
- Being tested
- sofosbuvir + ravidasvir
- Medical subject headings
- Hepatitis C
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
sofosbuvir + ravidasvirDrug
Also called ravisdasvir: PPI-668
combination of sofosbuvir + ravidasvir
| Study group | Role | What they receive |
|---|---|---|
| sofosbuvir + ravidasvir | Experimental | 12 weeks for non-cirrhotic patients, 24 weeks for cirrhotic patients Receives: Drug: sofosbuvir + ravidasvir |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 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
Related objective: to assess the efficacy of SOF-RDV at 4 and 24 weeks after the end of study treatment
Measured: 4 and 24 weeks after the end of the study treatment
Occurrence of on-treatment virologic failure among subjects not achieving SVR12
Defined as HCV RNA ≥ LLOQ at the end of the treatment period. Related objective: to assess the efficacy of SOF-RDV 12 weeks after the end of study treatment.
Measured: 12 weeks after the end of the study treatment
Occurrence of virologic breakthrough among subjects not achieving SVR12
Defined as either confirmed ≥ 1 log10 IU/mL increase in HCV RNA from nadir while on treatment or confirmed HCV RNA ≥ LLOQ if HCV RNA previously declined to < LLOQ while on treatment.
Related objective: to assess the efficacy of SOF-RDV 12 weeks after the end of study treatment.
Measured: 12 weeks after the end of the study treatment
Occurrence of virologic relapse among subjects not achieving SVR12
Defined as HCV RNA < LLOQ at the end of the treatment period but HCV RNA ≥ LLOQ during the post-treatment period.
Related objective: to assess the efficacy of SOF-RDV 12 weeks after the end of study treatment.
Measured: 12 weeks after the end of the study treatment
Occurrence of non-virologic failure among subjects not achieving SVR12
Defined as any failure that does not meet the virologic failure criteria (e.g. adverse event, lost to follow-up).
Related objective: to assess the efficacy of SOF-RDV 12 weeks after the end of study treatment.
Measured: 12 weeks after the end of the study treatment
Occurrence of premature treatment discontinuation and occurrence of premature study discontinuation (overall and by reason for premature discontinuation)
Related objective: to assess the safety of SOF-RDV
Measured: Through study completion (up to 36 weeks for non-cirrhotic patients and up to 48 weeks for cirrhotic patients)
Time to premature treatment discontinuation and time to premature study discontinuation
Related objective: to assess the safety of SOF-RDV
Measured: Through study completion (up to 36 weeks for non-cirrhotic patients and up to 48 weeks for cirrhotic patients)
Occurrence of the following events: TEAE, TEAE considered to be at least possibly related to at least one of the study drugs, TEAE leading to premature treatment discontinuation, TE laboratory abnormality, grade 3/4 TEAE, TESAE and death
Related objective: to assess the safety of SOF-RDV. TEAE: Treatment Emergent Adverse Event TESAE: Treatment Emergent Serious Adverse Event
Measured: Through study completion (up to 36 weeks for non-cirrhotic patients and up to 48 weeks for cirrhotic patients)
Time to first TEAE, time to first grade 3/4 TEAE and time to first TESAE
Related objective: to assess the safety of SOF-RDV. TEAE: Treatment Emergent Adverse Event TESAE: Treatment Emergent Serious Adverse Event
Measured: Through study completion (up to 36 weeks for non-cirrhotic patients and up to 48 weeks for cirrhotic patients)
Maximum plasma concentration (Cmax) of ravidasvir (and sofosbuvir if needed)
Related objective: to study the pharmacokinetics (PK) of SOF and RDV and to evaluate potential drug-drug interactions with antiretrovirals and, as needed, interactions with concomitant prescribed or non-prescribed drugs.
Measured: Intensive PK (stage 1 only): 4 weeks after treatment initiation; Sparse PK: 4, 8 and 12 weeks after treatment initiation
Baseline factors associated with SVR12 outcome
Related objective: to describe the subjects' demographic, clinical and biological characteristics and their relationship with SVR12.
Measured: Baseline and 12 weeks after the end of the study treatment
Change in the PROQOL-HCV domain scores from treatment initiation to 12 weeks after treatment completion
Related objective: to assess the subjects' quality of life before and after therapy.
PROQOL-HCV: Patient Reported Outcome Quality of Life survey for HCV, questionnaire that evaluates 7 domains, each domain scores range 0 to 100, where 100 corresponds to the best quality of life.
Measured: 12 weeks after the end of the study treatment
Changes in HCV NS5A sequences from treatment initiation in subjects not achieving SVR12
Related objective: to evaluate the presence of viral resistance-associated variants (RAVs) to SOF-RDV in patients with virological failure 12 weeks after treatment completion
Measured: 12 weeks after the end of the study treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Nov 2016 (estimated)
- Study startSep 2016
- Primary completionAug 2021 (estimated)
- Study completionMar 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for 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 2/3
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 603 participants (actual)
Sponsor and investigators
- Lead sponsor
- Drugs for Neglected Diseases
- Sponsor type
- University, hospital or other
- Collaborators
- Ministry of Health, Malaysia, Ministry of Health, Thailand, National Science and Technology Development Agency, Thailand
- Responsible party
- Sponsor
- Investigators
- Isabelle Andrieux-Meyer, MD, Study director, Drugs for Neglected DiseasesSoek-Siam Tan, MD, Principal investigator, Selayang HospitalSatawat Thongsawat, MD, Principal investigator, Chiang Mai Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02961426
- Sponsor's protocol ID
- DNDi-SOF/RDV-01-HCV
- Acronym
- STORM-C-1
- Status last verified
- Jan 2021
- First submitted
- 7 Sep 2016
- Last updated
- 20 Jan 2021
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Publications
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.
PubMed 33865507
Study at a glance
From the registry record, last updated by the sponsor on 20 Jan 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT02961426
- Acronym / sponsor ID
- STORM-C-1 / DNDi-SOF/RDV-01-HCV
- Conditions
- Hepatitis C
- Phase
- Phase 2/3
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 603 participants (actual)
- Lead sponsor
- Drugs for Neglected DiseasesUniversity, hospital or other
- Collaborators
- Ministry of Health, Malaysia, Ministry of Health, Thailand, National Science and Technology Development Agency, Thailand
- Study start
- Sep 2016 (actual)
- Primary completion
- Aug 2021 (estimated)
- Study completion
- Mar 2024 (estimated)
- First posted
- 11 Nov 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| sofosbuvir + ravidasvir | Experimental | Drug: sofosbuvir + ravidasvir12 weeks for non-cirrhotic patients, 24 weeks for cirrhotic patients |
Who may qualify
- Ages
- 18 to 69 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (11 listed)
- 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.
Key exclusion criteria (28 listed)
- 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:
- Patients with serum creatinine > 1.5 ULN or end stage renal disease
- Hepatitis B co-infection (HBsAg positive)
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 |
|---|---|---|
| sofosbuvir + ravidasvirAlso: ravisdasvir: PPI-668combination of sofosbuvir + ravidasvir | Drug | sofosbuvir + ravidasvir |
Primary outcome
Sustained Virological Response at 12 weeks post treatment completion (SVR12), as evidenced by HCV RNA level less than the lower limit of quantification
Time frame: 12 weeks after the end of the study treatment
Related objective: to assess the efficacy of sofosbuvir-ravidasvir (SOF-RDV) at 12 weeks after the end of study treatment
13 secondary outcomes
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
Time frame: 4 and 24 weeks after the end of the study treatment
Occurrence of on-treatment virologic failure among subjects not achieving SVR12
Time frame: 12 weeks after the end of the study treatment
Occurrence of virologic breakthrough among subjects not achieving SVR12
Time frame: 12 weeks after the end of the study treatment
Occurrence of virologic relapse among subjects not achieving SVR12
Time frame: 12 weeks after the end of the study treatment
Occurrence of non-virologic failure among subjects not achieving SVR12
Time frame: 12 weeks after the end of the study treatment
Occurrence of premature treatment discontinuation and occurrence of premature study discontinuation (overall and by reason for premature discontinuation)
Time frame: Through study completion (up to 36 weeks for non-cirrhotic patients and up to 48 weeks for cirrhotic patients)
Time to premature treatment discontinuation and time to premature study discontinuation
Time frame: Through study completion (up to 36 weeks for non-cirrhotic patients and up to 48 weeks for cirrhotic patients)
Occurrence of the following events: TEAE, TEAE considered to be at least possibly related to at least one of the study drugs, TEAE leading to premature treatment discontinuation, TE laboratory abnormality, grade 3/4 TEAE, TESAE and death
Time frame: Through study completion (up to 36 weeks for non-cirrhotic patients and up to 48 weeks for cirrhotic patients)
Time to first TEAE, time to first grade 3/4 TEAE and time to first TESAE
Time frame: Through study completion (up to 36 weeks for non-cirrhotic patients and up to 48 weeks for cirrhotic patients)
Maximum plasma concentration (Cmax) of ravidasvir (and sofosbuvir if needed)
Time frame: Intensive PK (stage 1 only): 4 weeks after treatment initiation; Sparse PK: 4, 8 and 12 weeks after treatment initiation
Baseline factors associated with SVR12 outcome
Time frame: Baseline and 12 weeks after the end of the study treatment
Change in the PROQOL-HCV domain scores from treatment initiation to 12 weeks after treatment completion
Time frame: 12 weeks after the end of the study treatment
Changes in HCV NS5A sequences from treatment initiation in subjects not achieving SVR12
Time frame: 12 weeks after the end of the study treatment
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Jan 2021.
- Derived from this study: PubMed 33865507Andrieux-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.
- Individual participant dataSharing planned: No
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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.
Isabelle Andrieux-Meyer, MD study director
Drugs for Neglected Diseases
Soek-Siam Tan, MD principal investigator
Selayang Hospital
Satawat Thongsawat, MD principal investigator
Chiang Mai Hospital
13 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2/3 study testing sofosbuvir + ravidasvir in people with Hepatitis C, run by Drugs for Neglected Diseases at 13 sites in 2 countries.
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 11 inclusion and 28 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: status not confirmed, as of the sponsor's last update on 20 Jan 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 13 sites in Malaysia, Thailand. Whether a site is taking part right now should be confirmed with that site. See every site.
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 combined 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.
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?
Results are not available in the source record.
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?
Sustained Virological Response at 12 weeks post treatment completion (SVR12), as evidenced by HCV RNA level less than the lower limit of quantification (time frame: 12 weeks after the end of the study treatment). 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 NCT02961426, 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 20 Jan 2021.