A Safety and Efficacy Study of SHR4640 and Febuxostat in Subjects With Hyperuricemia
A Phase II, MultiCenter, Double-Blind Study to Evaluate the Efficacy and Safety of SHR4640 and Febuxostat in Subjects With Hyperuricemia
1 other identifier
interventional
84
0 countries
N/A
Brief Summary
The objective of the study is to assess the Safety and Efficacy of SHR4640 and Febuxostat in patients with Hyperuricemia.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for phase_2
Started Dec 2019
Shorter than P25 for phase_2
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
November 26, 2019
CompletedFirst Posted
Study publicly available on registry
November 29, 2019
CompletedStudy Start
First participant enrolled
December 3, 2019
CompletedPrimary Completion
Last participant's last visit for primary outcome
July 30, 2020
CompletedStudy Completion
Last participant's last visit for all outcomes
August 30, 2020
CompletedDecember 2, 2019
November 1, 2019
8 months
November 26, 2019
November 28, 2019
Conditions
Outcome Measures
Primary Outcomes (1)
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)
Up to week 4
Secondary Outcomes (3)
Percentage of subjects with a serum uric level≤360μmol/L
At week1, 2, 3 and 4
Percentage change from baseline in serum uric level .
At week1, 2, 3 and 4
Actual change from baseline in serum uric level
At week1, 2, 3 and 4
Study Arms (3)
Treatment group A
EXPERIMENTALSHR4640 dose1 Oral Tablet plus Febuxostat dose1 Oral Tablet Day1\~Day28 qd.
Treatment group B
EXPERIMENTALSHR4640 dose1 Oral Tablet plus Febuxostat dose2 Oral Tablet Day1\~Day28 qd.
Treatment group C
EXPERIMENTALSHR4640 dose2 Oral Tablet plus Febuxostat dose3 Oral Tablet Day1\~Day28 qd.
Interventions
Eligibility Criteria
You may qualify if:
- 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.
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Liu Yi
West China Hospital
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- PARTICIPANT, INVESTIGATOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
November 26, 2019
First Posted
November 29, 2019
Study Start
December 3, 2019
Primary Completion
July 30, 2020
Study Completion
August 30, 2020
Last Updated
December 2, 2019
Record last verified: 2019-11
Data Sharing
- IPD Sharing
- Will not share