HyperuricemiaPhase 2NCT04180982
A Safety and Efficacy Study of SHR4640 and Febuxostat in Subjects With Hyperuricemia
A Phase 2 study testing SHR4640 dose1 plus Febuxostat dose1, SHR4640 dose1 plus Febuxostat dose2 and SHR4640 dose2 plus Febuxostat dose3 in people with Hyperuricemia, run by Jiangsu HengRui Medicine Co., Ltd..
Trial summary
The objective of the study is to assess the Safety and Efficacy of SHR4640 and Febuxostat in patients with Hyperuricemia. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Hyperuricemia
- What is being tested?
- SHR4640 dose1 plus Febuxostat dose1, SHR4640 dose1 plus Febuxostat dose2 and SHR4640 dose2 plus Febuxostat dose3
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 84 participants
- Where
- No sites listed yet
- Study dates
- 3 Dec 2019to 30 Aug 2020
- Phase
- Phase 2
- 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 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Subject has a body mass index ≥18 and ≤30 kg/m2;
- Screening sUA value ≥8mg/dl;
- Subject has no clinically relevant abnormalities in vital signs, ECG, physical examination，imaging examination or safety laboratory values.
Who cannot join
- Subject known or suspected of being sensitive to the study drugs or its ingredient；
- ALT、AST、TBIL>1.5ULN;
- History of kidney stones or screening kidney stones by B-ultrasound；
- History of malignancy；
- History of xanthinuria；
- Donated blood（≥400ml）within 3 months prior to screening or received transfusion of blood.
Trial locations and contacts
No sites are listed yet.
About this study
Official title: A Phase II, MultiCenter, Double-Blind Study to Evaluate the Efficacy and Safety of SHR4640 and Febuxostat in Subjects With Hyperuricemia
The objective of the study is to assess the Safety and Efficacy of SHR4640 and Febuxostat in patients with Hyperuricemia.
- Conditions
- Hyperuricemia
- Being tested
- SHR4640 dose1 plus Febuxostat dose1, SHR4640 dose1 plus Febuxostat dose2, SHR4640 dose2 plus Febuxostat dose3
- Medical subject headings
- Hyperuricemia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SHR4640 dose1 plus Febuxostat dose1Drug
Tablet,dose1,QD
SHR4640 dose1 plus Febuxostat dose2Drug
Tablet,dose1, dose2 QD
SHR4640 dose2 plus Febuxostat dose3Drug
Tablet,dose2, dose3 QD
| Study group | Role | What they receive |
|---|---|---|
| Treatment group A | Experimental | SHR4640 dose1 Oral Tablet plus Febuxostat dose1 Oral Tablet Day1~Day28 qd. Receives: Drug: SHR4640 dose1 plus Febuxostat dose1 |
| Treatment group B | Experimental | SHR4640 dose1 Oral Tablet plus Febuxostat dose2 Oral Tablet Day1~Day28 qd. Receives: Drug: SHR4640 dose1 plus Febuxostat dose2 |
| Treatment group C | Experimental | SHR4640 dose2 Oral Tablet plus Febuxostat dose3 Oral Tablet Day1~Day28 qd. Receives: Drug: SHR4640 dose2 plus Febuxostat dose3 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Adverse Events(AEs) and Serious Adverse Events(SAEs)
Incidence of AEs and SAEs, incidence of Treatment-Emergent Adverse Events, incidence of drug related adverse events (safety and tolerability)
Measured: Up to week 4
Secondary outcomes (3)
Percentage of subjects with a serum uric level≤360μmol/L
Measured: At week1, 2, 3 and 4
Percentage change from baseline in serum uric level .
Measured: At week1, 2, 3 and 4
Actual change from baseline in serum uric level
Measured: At week1, 2, 3 and 4
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Nov 2019
- Study start3 Dec 2019 (estimated)
- Primary completion30 Jul 2020 (estimated)
- Study completion30 Aug 2020 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HyperuricemiaStudies of the same condition, open and under way.
- More trials run by Jiangsu HengRui Medicine Co., Ltd.The sponsor's other registered studies.
- 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
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 84 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Jiangsu HengRui Medicine Co., Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Liu Yi, Principal investigator, West China Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04180982
- Sponsor's protocol ID
- SHR4640-202
- Status last verified
- Nov 2019
- First submitted
- 26 Nov 2019
- Last updated
- 2 Dec 2019
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 2 Dec 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase II, MultiCenter, Double-Blind Study to Evaluate the Efficacy and Safety of SHR4640 and Febuxostat in Subjects With Hyperuricemia
- ClinicalTrials.gov ID
- NCT04180982
- Acronym / sponsor ID
- SHR4640-202
- Conditions
- Hyperuricemia
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 84 participants (estimated)
- Lead sponsor
- Jiangsu HengRui Medicine Co., Ltd.Industry (pharma, biotech, devices)
- Study start
- 3 Dec 2019 (estimated)
- Primary completion
- 30 Jul 2020 (estimated)
- Study completion
- 30 Aug 2020 (estimated)
- First posted
- 29 Nov 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.
The objective of the study is to assess the Safety and Efficacy of SHR4640 and Febuxostat in patients with Hyperuricemia.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Treatment group A | Experimental | Drug: SHR4640 dose1 plus Febuxostat dose1SHR4640 dose1 Oral Tablet plus Febuxostat dose1 Oral Tablet Day1~Day28 qd. |
| Treatment group B | Experimental | Drug: SHR4640 dose1 plus Febuxostat dose2SHR4640 dose1 Oral Tablet plus Febuxostat dose2 Oral Tablet Day1~Day28 qd. |
| Treatment group C | Experimental | Drug: SHR4640 dose2 plus Febuxostat dose3SHR4640 dose2 Oral Tablet plus Febuxostat dose3 Oral Tablet Day1~Day28 qd. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Subject has a body mass index ≥18 and ≤30 kg/m2;
- Screening sUA value ≥8mg/dl;
- Subject has no clinically relevant abnormalities in vital signs, ECG, physical examination，imaging examination or safety laboratory values.
Key exclusion criteria (6 listed)
- Subject known or suspected of being sensitive to the study drugs or its ingredient；
- ALT、AST、TBIL>1.5ULN;
- History of kidney stones or screening kidney stones by B-ultrasound；
- History of malignancy；
- History of xanthinuria；
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 |
|---|---|---|
| SHR4640 dose1 plus Febuxostat dose1Tablet,dose1,QD | Drug | Treatment group A |
| SHR4640 dose1 plus Febuxostat dose2Tablet,dose1, dose2 QD | Drug | Treatment group B |
| SHR4640 dose2 plus Febuxostat dose3Tablet,dose2, dose3 QD | Drug | Treatment group C |
Primary outcome
Adverse Events(AEs) and Serious Adverse Events(SAEs)
Time frame: Up to week 4
Incidence of AEs and SAEs, incidence of Treatment-Emergent Adverse Events, incidence of drug related adverse events (safety and tolerability)
3 secondary outcomes
Percentage of subjects with a serum uric level≤360μmol/L
Time frame: At week1, 2, 3 and 4
Percentage change from baseline in serum uric level .
Time frame: At week1, 2, 3 and 4
Actual change from baseline in serum uric level
Time frame: At week1, 2, 3 and 4
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Dec 2019.
- 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.
Liu Yi principal investigator
West China Hospital
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing SHR4640 dose1 plus Febuxostat dose1, SHR4640 dose1 plus Febuxostat dose2 and SHR4640 dose2 plus Febuxostat dose3 in people with Hyperuricemia, run by Jiangsu HengRui Medicine Co., Ltd..
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 3 inclusion and 6 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 2 Dec 2019. Status can change between updates, so confirm with the study contact before making plans.
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 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
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?
Contact Liu Yi (028-85423237, hxyyhfb@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Adverse Events(AEs) and Serious Adverse Events(SAEs) (time frame: Up to week 4). 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 2 Dec 2019.