- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03349645
Open Label Extension to Assess the Safety of Long-Term Treatment With Ampion for Severe Osteoarthritis (OA) of the Knee
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
Study Overview
Status
Conditions
Intervention / Treatment
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.
Study Type
Enrollment (Actual)
Phase
- Phase 3
Contacts and Locations
Study Locations
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Alabama
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Birmingham, Alabama, United States, 35205
- Central Research Associates, Inc.
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California
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Encinitas, California, United States, 92024
- CORE Orthopaedic Medical Center
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Fullerton, California, United States, 92835
- St. Joseph Heritage
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Thousand Oaks, California, United States, 91360
- Westlake Medical Research
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Georgia
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Marietta, Georgia, United States, 30060
- Drug Studies America
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Illinois
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Blue Island, Illinois, United States, 60406
- Healthcare Research Netword
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Kansas
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Wichita, Kansas, United States, 67207
- Heartland Research Associates
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Missouri
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Hazelwood, Missouri, United States, 63042
- Healthcare Network Research
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South Carolina
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North Charleston, South Carolina, United States, 29406
- Coastal Carolina Center at Lowcountry Orthopaedics
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Texas
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Austin, Texas, United States, 78745
- Tekton Research
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Washington
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Bellevue, Washington, United States, 98007
- Northwest Clinical Research Center
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
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.
- No analgesia (including acetaminophen [paracetamol]) taken 24 hours prior to an efficacy measure
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
- Any pain that could interfere with the assessment of study knee pain (e.g. pain in any other part of the lower extremities, pain radiating to the knee)
- Any pharmacological or non-pharmacological treatment targeting OA started or changed 4 weeks prior to entry into the OLE study, or likely to be changed during the duration of the OLE study
- Pregnancy or planning to become pregnant during the study
Use of the following medications:
- No IA injected pain medications in the study knee during the study. No Hyaluronic Acid (HA) or steroid injections in the study knee at least 12 weeks prior to Day 84 of the Extension Study. HA and steroid injections in the contralateral knee (non-study knee) are acceptable while on study except ± 14 days of an Ampion injection in the study knee.
- No analgesics containing opioids
- NSAIDs are not permitted ± 72 hours before/after injections at in-office visits; acetaminophen is available as a rescue medication during the study from the provided supply
- No topical treatment on the study knee during the study
- No significant anticoagulant therapy (e.g. Heparin or Lovenox) during the study (treatment such as Aspirin and Plavix are allowed)
- No systemic treatments that may interfere with safety or efficacy assessments during the study
- No immunosuppressants
- No use of corticosteroids
- No human albumin treatment in the 3 months prior to the AP-003-C Main Study or interim period prior to enrollment into the OLE study. No human albumin treatment throughout the duration of the OLE study
Study Plan
How is the study designed?
Design Details
- Primary Purpose: TREATMENT
- Allocation: NA
- Interventional Model: SINGLE_GROUP
- Masking: NONE
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
EXPERIMENTAL: AMPION™ 4 mL dose
4 mL intra-articular injection of AMPION™
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4 mL injection of AMPION™
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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).
|
52 weeks
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Collaborators and Investigators
Sponsor
Study record dates
Study Major Dates
Study Start (ACTUAL)
Primary Completion (ACTUAL)
Study Completion (ACTUAL)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (ACTUAL)
Study Record Updates
Last Update Posted (ACTUAL)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- AP-003-C-OLE
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Severe Osteoarthritis of the Knee
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-
Tris Pharma, Inc.Forest LaboratoriesCompletedModerate to Severe Chronic Pain Due to Osteoarthritis of the KneeUnited States
-
Taiwan Liposome CompanyCompletedOSTEOARTHRITIS OF THE KNEETaiwan, United States
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University Hospital, GhentCompletedOsteoarthritis of the Knee JointBelgium
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Bone Therapeutics S.ANordic Bioscience A/SCompletedSymptomatic Osteoarthritis of the KneeDenmark, Belgium, United Kingdom, Czechia, Hong Kong, Moldova, Republic of, Poland
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Rush University Medical CenterWithdrawnSymptomatic Osteoarthritis of the Knee
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Region SkaneRecruitingOsteoarthritis of the Knee or HipSweden
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UMC UtrechtCompletedMedial Compartment Osteoarthritis of the KneeNetherlands
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Massachusetts General HospitalGöteborg University; Seoul National University Hospital; Ulsan University Hospital and other collaboratorsUnknownOsteoarthritis of the Knee | Traumatic Arthritis of the KneeUnited States
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Hospital General de Jerez de la FronteraZiekenhuis Oost-LimburgCompletedPainful Osteoarthritis of the KneeSpain
Clinical Trials on 4 mL injection of AMPION™
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Ampio Pharmaceuticals. Inc.Completed
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Ampio Pharmaceuticals. Inc.CompletedOsteoarthritis of the KneeUnited States
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Ampio Pharmaceuticals. Inc.Completed
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Ampio Pharmaceuticals. Inc.CompletedOsteoarthritis of the KneeUnited States
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Shanghai Henlius BiotechActive, not recruitingMetastatic Colorectal Cancer (mCRC)China
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Merck Sharp & Dohme LLCCompleted
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Judit Pich MartínezRecruiting