An Open Label Extension Study to Assess the Safety of Long-Term Treatment With a 4 mL Intra-Articular Injection of Ampion in Adults With Pain Due to Severe Osteoarthritis of the Knee

Ampio Pharmaceuticals. Inc.11 sites in 1 country94 target enrollmentDecember 8, 2017

ConditionsSevere Osteoarthritis of the Knee

Overview

Phase: Phase 3
Intervention: Not specified
Conditions: Severe Osteoarthritis of the Knee
Sponsor: Ampio Pharmaceuticals. Inc.
Enrollment: 94
Locations: 11
Primary Endpoint: Incidence and Severity of Treatment-Emergent Adverse Events (TEAEs)
Status: Terminated
Last Updated: 3 years ago

Overview Investigators Eligibility Criteria Outcomes Sites Similar Trials

Overview

Brief Summary

This Open Label Extension (OLE) study will assess the safety of long-term treatment with a 4 mL intra-articular injection of Ampion™ in adults with pain due to severe osteoarthritis of the knee

Detailed Description

An Open Label Extension (OLE) study will assess the safety of long-term treatment with a 4 mL intra-articular injection of Ampion™ in adults with pain due to severe osteoarthritis of the knee. The primary trial objective was to evaluate the safety of a 4-mL intra-articular (IA) injection of Ampion with repeat dosing every 12 weeks for 52 weeks with five total injections of Ampion.

Registry

clinicaltrials.gov

Start Date

December 8, 2017

End Date

October 4, 2018

Last Updated

3 years ago

Study Type

Interventional

Study Design

Single Group

Sex

All

Investigators

Sponsor

Ampio Pharmaceuticals. Inc.

Responsible Party

Sponsor

Eligibility Criteria

Inclusion Criteria

•Subjects who completed the AP-003-C Main study and have not developed any exclusionary criteria
•Able to provide written informed consent to participate in the study
•Willing and able to comply with all study requirements and instructions of the site study staff
•Male or female, 40 years to 85 years old (inclusive), as assessed in the AP-003-C Main Study
•Must be ambulatory, as assessed in the AP-003-C Main Study
•Study knee must have a clinical diagnosis of OA and supported by radiological evidence (Kellgren Lawrence Grade IV) as assessed in the AP-003-C Main Study.
•Moderate to moderately-severe OA pain in the study knee (rating of at least 1.5 on the WOMAC Index 3.1 5-point Likert Pain Subscale), as assessed in the AP-003-C Main Study
•Moderate to moderately-severe OA function in the study knee (rating of at least 1.5 on the WOMAC Index 3.1 5-point Likert Function Subscale), as assessed in the AP-003-C Main Study
•WOMAC A, 5-point Likert pain subscale \<1.5 in the contralateral knee, as assessed in the AP-003-C Main Study
•Ability to discontinue NSAID ± 72 hours before/after injections (in-office visits). Low-dose Aspirin (81 mg) is allowed during the study but must not be taken at least 24 hours prior to in-office visits.

Exclusion Criteria

•As a result of medical review and screening investigation, the Principal Investigator considers the patient unfit for the study
•Known clinically significant liver abnormality (e.g., cirrhosis, transplant, etc.)
•A history of allergic reactions to human albumin (reaction to non-human albumin such as egg albumin is not an exclusion criterion)
•A history of allergic reactions to excipients in 5% human albumin (N-acetyltryptophan, sodium caprylate)
•Presence of tense effusions
•Inflammatory or crystal arthropathies, acute fractures, history of aseptic necrosis or joint replacement in the affected knee
•Isolated patella femoral syndrome, also known as chondromalacia
•Any other disease or condition interfering with the free use and evaluation of the index knee for the duration of the trial (e.g. cancer, congenital defects, spine osteoarthritis)
•Major injury to the index knee within the last 12 months
•Severe hip osteoarthritis ipsilateral to the index knee

Outcomes

Primary Outcomes

Incidence and Severity of Treatment-Emergent Adverse Events (TEAEs)

Time Frame: 52 weeks

Incidence and severity of treatment emergent adverse events (TEAEs) evaluated up to 52 weeks, including the 12 weeks in the Main study AP-003-C (NCT03182686).