Phase IIa Trial of Oral SSS17 for Post-Arthroplasty Anemia
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: SSS17 Capsule (6 Dose Levels), Placebo Drug.
- Who it may be relevant to
- Registry conditions: Postoperative Anemia, Arthroplasty, Replacement, Hip, Arthroplasty, Replacement, Knee. Basic parameters: 18 years — 70 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- China
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
Official title
A Multicenter, Randomized, Double-Blind, Placebo-Controlled Phase IIa Trial to Evaluate the Efficacy and Safety of Oral SSS17 Capsules in the Treatment of Anemia Following Total Hip or Knee Arthroplasty
Overview
To assess the safety, tolerability, efficacy, and pharmacokinetic/pharmacodynamic (PK/PD) characteristics of orally administered SSS17 capsules in patients with postoperative anemia following elective total hip or knee arthroplasty.
Interventions
- Drug SSS17 Capsule (6 Dose Levels)
Arm1 ： This dose-ranging study evaluates 6 dose levels of oral SSS17 capsules under two regimens: Once weekly、 Twice weekly - Drug Placebo Drug
Arm2：placebo The placebo intervention was matched with the six dose levels of SSS17, with each dose level assigning participants in a ratio of 4:1 (SSS17 to placebo).
Primary outcome measures
- Change from baseline in hemoglobin [Time frame: Day 8，Day 15，Day 29]
Secondary outcome measures (1)
- Proportion of subjects requiring transfusion and transfusion volume [Time frame: Day 29]
Eligibility criteria
Inclusion criteria
- Signed informed consent obtained
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- Age 18-70 years (inclusive)
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- Candidates for hip/knee arthroplasty
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- No DVT on pre-op venous ultrasound
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- Screening Hb 80-110 g/L (no transfusion indication) - 6. Commitment to effective contraception
Exclusion criteria
- Hypersensitivity to the investigational product or any of its components
- Any other condition causing chronic anemia
- Coagulopathy or unstable anticoagulant dosing during screening
- Any of the following laboratory abnormalities at screening:
- Serum albumin <35 g/L
- ALT or AST >3×ULN
- Active infections or carrier status including:
- Known HIV infection
- Active syphilis
- Active HBV infection (HBsAg-positive with HBV DNA >10³ copies/mL)
- Active HCV infection (anti-HCV positive with detectable HCV RNA)
- Acute joint injury with active trauma or infection at screening
- Cognitive impairment or psychiatric disorders,current or history of epilepsy
- Treatment with ESAs (erythropoiesis-stimulating agents) or HIF inhibitors within 30 days prior to dosing
- History of severe thromboembolic events or hematopoietic disorders
- Malignancy history
- Severe cardiovascular diseases including:
- Unstable coronary artery disease
- Heart failure (NYHA Class III/IV)
- Myocardial infarction/stroke 12 .Poorly controlled hypertension
13\. Alcohol abuse 14.Pregnancy or lactation 15.Participation in other drug trials within 3 months prior to enrollment 16.Any other condition deemed by the Investigator to compromise subject safety or trial validity
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Quadruple blind
- Primary purpose
- Treatment
Study locations
China · 1 center
- Peking University People's Hospital — Beijing
Identifiers
NCT: NCT07007936 · SSS17-202