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Study to Evaluate Efficacy and Safety of BGE-117 in Moderately to Severely Anemic Older Individuals After Major Hip Surgery

NCT05152641 · Status: WITHDRAWN · Phase: PHASE2 · Type: INTERVENTIONAL

Last updated 2022-05-05

No results posted yet for this study

Summary

The purpose of this study is to explore the safety and tolerability of BGE-117 and gain information on the effectiveness of different doses when given to patients 65 years or older with moderate to severe anemia following major hip surgery. BGE-117 is given once daily in a capsule by mouth for up to 12 weeks. Patients are also given oral iron supplements. Anemia following surgery has been associated with decreases in patient functioning. This study will measure improvement of anemia, as well as various patient functioning.

Conditions

  • Acute Posthemorrhagic Anemia

Interventions

DRUG

BGE-117, 4mg

BGE-117, 4mg Capsules

DIETARY_SUPPLEMENT

Ferrous Sulfate

Ferrous Sulfate, 325mg Tablets

OTHER

Matching Placebo

Matching Placebo to BGE-117 Capsules

DRUG

BGE-117, 12mg

BGE-117, 12mg Capsules

Sponsors & Collaborators

  • BioAge Labs, Inc.

    lead INDUSTRY

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
65 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2022-04-30
Primary Completion
2023-04-30
Completion
2024-07-31
FDA Drug
Yes

Countries

  • Australia

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05152641 on ClinicalTrials.gov