Phase IIa Trial of Oral SSS17 for Post-Arthroplasty Anemia
Trial statusNot yet recruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
Age18-70
SponsorShenyang Sunshine Pharmaceutical Co., LTD.
About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Signed informed consent obtained
Age 18-70 years (inclusive)
Candidates for hip/knee arthroplasty
No DVT on pre-op venous ultrasound
Disqualifiers
Hypersensitivity to the investigational product or any of its components
Any other condition causing chronic anemia
Coagulopathy or unstable anticoagulant dosing during screening
Serum albumin <35 g/L
Trial design
Design model
Parallel
Treatments tested in this trial
SSS17 Capsule (6 Dose Levels)
DrugArm1 ： This dose-ranging study evaluates 6 dose levels of oral SSS17 capsules under two regimens: Once weekly、 Twice weekly
Placebo Drug
DrugArm2：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).
Treatment groups
90 Participants
are divided into 2 treatment groupsGroup A: SSS17Experimental treatment 2 interventions
Group B: placeboPlacebo comparator 2 interventions
Trial outcomes
Primary outcomes
1
Change from baseline in hemoglobin
Time frame
Day 8，Day 15，Day 29Secondary outcomes
1
Proportion of subjects requiring transfusion and transfusion volume
Time frame
Day 29Sponsors and contacts
Click on the lead sponsor to view all of their trials.
Source ClinicalTrials.gov
This trial is not recruiting at the moment. You can still explore other options: