Hepatitis C Virus InfectionPhase 3NCT04001608
Study of Seraprevir in Combination With Sofosbuvir in Chronic Genotype 1 Hepatitis C Virus Infection Patients
A Phase 3 study testing Seraprevir and Sofosbuvir in people with Hepatitis C Virus Infection, run by Ginkgopharma CO., LTD at 22 sites in China.
Trial summary
This study was to assess the safety and efficacy of Seraprevir in combination with sofosbuvir administered for 12 weeks in patients with Hepatitis C (HCV) genotype1. Efficacy was assessed by the rate of sustained viral response (SVR) 12 weeks after the discontinuation of therapy (SVR12). Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Hepatitis C Virus Infection
- What is being tested?
- Seraprevir and Sofosbuvir
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 206 participants
- Where
- 22 sitesChina
- Study dates
- 17 Oct 2018to 30 Nov 2019
- Phase
- Phase 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 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Hepatitis C virus (HCV) genotype 1 infection (confirmed at screening).
- HCVRNA greater than 10,000 IU/mL at screening.
- Participant must be willing and able to comply with the protocol requirements.
- weight was more than 40 kg.
- age is between 18-75,either sex.
Who cannot join
- Co-infection with hepatitis B virus or human immunodeficiency virus (HIV).
- Infection with HCV non-genotype 1,or Infection with mixed genotype,or Genotype cannot be confirmed.
- Medical history of major functional organ transplantation.
- Suffering from serious blood system disease(such us Thalassemia/Sickle Cell Anemia).
- Participation in a clinical study within 3 months prior to first dose
Trial locations and contacts
22 sites in 1 country.
22 sites in 1 country
China22 sites
Beijing Ditan Hospital,Capital Medical University
Beijing, Beijing Municipality
Beijing Friendship Hospital,Capital Medical University
Beijing, Beijing Municipality
Beijing YouAn Hospital ,Capital Medical University
Beijing, Beijing Municipality
The first hospital of JILIN university.
Changchun, Jilin, 130000
Chengdu Public Health Medical Center
Chengdu, Sichuan
Sichuan Province General Hospital
Chengdu, Sichuan
Chongqing Public Health Medical Center
Chongqing, Chongqing Municipality
Chongqing Sanxia Center Hospital
Chongqing, Chongqing Municipality
The First Affiliated Hospital Of Guangxi Medical University
Guangxi, Nanning
Huzhou Center Hospital
Huzhou, Zhejiang
Liuzhou General Hospital
Liuzhou, Guangxi
Traditional Chinese Medical Hospital Affiliated To Southwest Medical University
Luzhou, Sichaun
The First Hospital Of Hebei Medical University
Shijiazhuang, Hebei
First Hospital Of Shanxi Medical University
Taiyuan, Shanxi
First Affiliated Hospital Of Xinjiang Medical University
Ürümqi, Xinjiang
Traditional Chinese Medical Hospital Uygur Autonomous Region
Ürümqi, Xinjiang
Tongji Hospital Affiliated To Tongji Medical College Huazhong University Of Science And technology
Wuhan, Hubei
Wuhan Medical Treatment Center
Wuhan, Hubei
Wuxi No.5 People's Hospital
Wuxi, Jiangsu
The Affiliated Hospital OF Xuzhou Medical University
Xuzhou, Jiangsu
The Sixth People's Hospital Of Zhengzhou
Zhengzhou, Henan
Affiliated Hospital Of Zunyi Medical University
Zunyi, Guizhou
About this study
Official title: A Phase 3, Multicenter, Open-Label, Single-Arm Study to Investigate the Efficacy and Safety of a 12-Week Regimen of Seraprevir in Combination With Sofosbuvir in Patients With Chronic Genotype 1 Hepatitis C Virus Infection.
This study was to assess the safety and efficacy of Seraprevir in combination with sofosbuvir administered for 12 weeks in patients with Hepatitis C (HCV) genotype1. Efficacy was assessed by the rate of sustained viral response (SVR) 12 weeks after the discontinuation of therapy (SVR12).
- Conditions
- Hepatitis C Virus Infection
- Being tested
- Seraprevir, Sofosbuvir
- Medical subject headings
- Hepatitis C
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SeraprevirDrug
Also called GP205
Subjects will receive oral tablets of Seraprevir 100 mg, twice a day from Day 1 up to Week 12
SofosbuvirDrug
Also called sovaldi
Subjects will receive oral tablet of sofosbuvir 400 mg, once a day from Day 1 up to Week 12
| Study group | Role | What they receive |
|---|---|---|
| Seraprevir and sofosbuvir | Experimental | Subjects will receive oral tablets of Seraprevir 100mg twice a day along with oral tablet of sofosbuvir 400 mg,once a day from Day 1 up to Week 12. Receives: Drug: Seraprevir; Drug: Sofosbuvir |
What is being measured
The primary outcome is the main question the study is designed to answer.
Percentage of Participants Achieving a Sustained Virologic Response 12 Weeks After the Actual End of Treatment（SVR12）
SVR12 is defined as HCV RNA < the lower limit of quantification (LLOQ; ie, < 15 IU/mL) 12 weeks following the last dose of study drug.
Measured: Posttreatment Week 12
Secondary outcomes (2)
Percentage of Participants Achieving a Sustained Virologic Response 4 Weeks After the Actual End of Treatment (SVR4)
SVR4 is defined as HCV RNA < LLOQ at 4 weeks following the last dose of study drug.
Measured: Posttreatment Week 4
Percentage of Participants Achieving a On-treatment Virologic Response
Percentage of participants who achieved HCV RNA <LLOQ at week 1,week 2,week 4,week8,week 12.
Measured: week 1,week 2,week 4,week8,week 12
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Jun 2019
- Study start17 Oct 2018
- Primary completion31 Jul 2019 (estimated)
- Study completion30 Nov 2019 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Hepatitis C Virus InfectionStudies 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 3
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 206 participants (actual)
Sponsor and investigators
- Lead sponsor
- Ginkgopharma CO., LTD
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Xuegang Wu, Study director, Ginkgo Pharma Co., Ltd.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04001608
- Sponsor's protocol ID
- GP205-1801
- Status last verified
- Jun 2019
- First submitted
- 21 Jun 2019
- Last updated
- 28 Jun 2019
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 28 Jun 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 3, Multicenter, Open-Label, Single-Arm Study to Investigate the Efficacy and Safety of a 12-Week Regimen of Seraprevir in Combination With Sofosbuvir in Patients With Chronic Genotype 1 Hepatitis C Virus Infection.
- ClinicalTrials.gov ID
- NCT04001608
- Acronym / sponsor ID
- GP205-1801
- Conditions
- Hepatitis C Virus Infection
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 206 participants (actual)
- Lead sponsor
- Ginkgopharma CO., LTDIndustry (pharma, biotech, devices)
- Study start
- 17 Oct 2018 (actual)
- Primary completion
- 31 Jul 2019 (estimated)
- Study completion
- 30 Nov 2019 (estimated)
- First posted
- 28 Jun 2019 (actual)
- 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 study was to assess the safety and efficacy of Seraprevir in combination with sofosbuvir administered for 12 weeks in patients with Hepatitis C (HCV) genotype1. Efficacy was assessed by the rate of sustained viral response (SVR) 12 weeks after the discontinuation of therapy (SVR12).
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Seraprevir and sofosbuvir | Experimental | Drug: Seraprevir, Drug: SofosbuvirSubjects will receive oral tablets of Seraprevir 100mg twice a day along with oral tablet of sofosbuvir 400 mg,once a day from Day 1 up to Week 12. |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Hepatitis C virus (HCV) genotype 1 infection (confirmed at screening).
- HCVRNA greater than 10,000 IU/mL at screening.
- Participant must be willing and able to comply with the protocol requirements.
- weight was more than 40 kg.
- age is between 18-75,either sex.
Key exclusion criteria (5 listed)
- Co-infection with hepatitis B virus or human immunodeficiency virus (HIV).
- Infection with HCV non-genotype 1,or Infection with mixed genotype,or Genotype cannot be confirmed.
- Medical history of major functional organ transplantation.
- Suffering from serious blood system disease(such us Thalassemia/Sickle Cell Anemia).
- Participation in a clinical study within 3 months prior to first dose
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 |
|---|---|---|
| SeraprevirAlso: GP205Subjects will receive oral tablets of Seraprevir 100 mg, twice a day from Day 1 up to Week 12 | Drug | Seraprevir and sofosbuvir |
| SofosbuvirAlso: sovaldiSubjects will receive oral tablet of sofosbuvir 400 mg, once a day from Day 1 up to Week 12 | Drug | Seraprevir and sofosbuvir |
Primary outcome
Percentage of Participants Achieving a Sustained Virologic Response 12 Weeks After the Actual End of Treatment（SVR12）
Time frame: Posttreatment Week 12
SVR12 is defined as HCV RNA < the lower limit of quantification (LLOQ; ie, < 15 IU/mL) 12 weeks following the last dose of study drug.
2 secondary outcomes
Percentage of Participants Achieving a Sustained Virologic Response 4 Weeks After the Actual End of Treatment (SVR4)
Time frame: Posttreatment Week 4
Percentage of Participants Achieving a On-treatment Virologic Response
Time frame: week 1,week 2,week 4,week8,week 12
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Jun 2019.
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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.
Xuegang Wu study director
Ginkgo Pharma Co., Ltd.
22 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Seraprevir and Sofosbuvir in people with Hepatitis C Virus Infection, run by Ginkgopharma CO., LTD at 22 sites in China.
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 5 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: status not confirmed, as of the sponsor's last update on 28 Jun 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 22 sites in China. 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 phase mean?
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?
Percentage of Participants Achieving a Sustained Virologic Response 12 Weeks After the Actual End of Treatment（SVR12） (time frame: Posttreatment Week 12). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 28 Jun 2019.