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An Open Label Extension Study to Assess the Safety of Long-Term Treatment With Ampion for Severe OA of the Knee

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03349645
Recruitment Status : Terminated (Study terminated by Sponsor before completion due to absence of significant safety findings.)
First Posted : November 21, 2017
Last Update Posted : June 20, 2019
Sponsor:
Information provided by (Responsible Party):
Ampio Pharmaceuticals. Inc.

Brief Summary:
An Open Label Extension (OLE) 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

Condition or disease Intervention/treatment Phase
Severe Osteoarthritis of the Knee Biological: Ampion Phase 3

Detailed Description:

Patients enrolled in AP-003-C Main Study will be offered the option to roll-over to the open label extension study at the final visit of the Main Study (Week 12).

Approximately 171 subjects with knee pain due to severe osteoarthritis of the knee (KL IV) may enroll in the 40-week OLE study. The OLE Study allows for a 60-day screening window from Week 12 of the Main Study for enrollment in the Extension study. Extension study visits will include 9 visits: Week 12 in-office visit (Day 84± 60 days), a 24-hour post-injection follow-up call, Week 24 in-office visit (Day 168 ± 7 days), a 24-hour, post-injection follow-up call, Week 36 in-office visit (Day 252 ± 7 days), a 24-hour, post-injection follow-up call, Week 48 in-office visit (Day 336 ± 7 days ), a 24-hour, post-injection follow-up call, and a Week 52 final visit (Day 364 ± 7 days ).

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 94 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Intervention Model Description: Open Label
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: 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
Actual Study Start Date : December 8, 2017
Actual Primary Completion Date : October 4, 2018
Actual Study Completion Date : October 4, 2018

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Osteoarthritis

Arm Intervention/treatment
Experimental: Ampion
4 mL Ampion (<5 kilodatlon (kDa) ultrafiltrate of 5% Human Serum Albumin (HSA)), solution
Biological: Ampion
Ampion (<5 kilodalton (kDa) ultrafiltrate of 5% Human Serum Albumin (HSA), solution, 4 mL




Primary Outcome Measures :
  1. Evaluate the incidence and severity of treatment-emergent adverse events (TEAEs) [ Time Frame: 52 weeks ]


Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   40 Years to 85 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. Subjects who completed the AP-003-C Main study and have not developed any exclusionary criteria
  2. Able to provide written informed consent to participate in the study
  3. Willing and able to comply with all study requirements and instructions of the site study staff
  4. Male or female, 40 years to 85 years old (inclusive), as assessed in the AP-003-C Main Study
  5. Must be ambulatory, as assessed in the AP-003-C Main Study
  6. 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.
  7. 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
  8. 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
  9. WOMAC A, 5-point Likert pain subscale <1.5 in the contralateral knee, as assessed in the AP-003-C Main Study
  10. 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.
  11. No analgesia (including acetaminophen [paracetamol]) taken 24 hours prior to an efficacy measure

Exclusion Criteria:

  1. As a result of medical review and screening investigation, the Principal Investigator considers the patient unfit for the study
  2. Known clinically significant liver abnormality (e.g., cirrhosis, transplant, etc.)
  3. A history of allergic reactions to human albumin (reaction to non-human albumin such as egg albumin is not an exclusion criterion)
  4. A history of allergic reactions to excipients in 5% human albumin (N-acetyltryptophan, sodium caprylate)
  5. Presence of tense effusions
  6. Inflammatory or crystal arthropathies, acute fractures, history of aseptic necrosis or joint replacement in the affected knee
  7. Isolated patella femoral syndrome, also known as chondromalacia
  8. 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)
  9. Major injury to the index knee within the last 12 months
  10. Severe hip osteoarthritis ipsilateral to the index knee
  11. 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)
  12. 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
  13. Pregnancy or planning to become pregnant during the study
  14. Use of the following medications:

    1. 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.
    2. No analgesics containing opioids
    3. 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
    4. No topical treatment on the study knee during the study
    5. No significant anticoagulant therapy (e.g. Heparin or Lovenox) during the study (treatment such as Aspirin and Plavix are allowed)
    6. No systemic treatments that may interfere with safety or efficacy assessments during the study
    7. No immunosuppressants
    8. No use of corticosteroids
    9. 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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03349645


Locations
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United States, Alabama
Central Research Associates, Inc.
Birmingham, Alabama, United States, 35205
United States, California
CORE Orthopaedic Medical Center
Encinitas, California, United States, 92024
St. Joseph Heritage
Fullerton, California, United States, 92835
Westlake Medical Research
Thousand Oaks, California, United States, 91360
United States, Georgia
Drug Studies America
Marietta, Georgia, United States, 30060
United States, Illinois
Healthcare Research Netword
Blue Island, Illinois, United States, 60406
United States, Kansas
Heartland Research Associates
Wichita, Kansas, United States, 67207
United States, Missouri
Healthcare Network Research
Hazelwood, Missouri, United States, 63042
United States, South Carolina
Coastal Carolina Center at Lowcountry Orthopaedics
North Charleston, South Carolina, United States, 29406
United States, Texas
Tekton Research
Austin, Texas, United States, 78745
United States, Washington
Northwest Clinical Research Center
Bellevue, Washington, United States, 98007
Sponsors and Collaborators
Ampio Pharmaceuticals. Inc.
Investigators
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Study Director: David Bar-Or, MD Ampio Pharmaceuticals. Inc.
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Responsible Party: Ampio Pharmaceuticals. Inc.
ClinicalTrials.gov Identifier: NCT03349645    
Other Study ID Numbers: AP-003-C-OLE
First Posted: November 21, 2017    Key Record Dates
Last Update Posted: June 20, 2019
Last Verified: June 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Osteoarthritis
Osteoarthritis, Knee
Arthritis
Joint Diseases
Musculoskeletal Diseases
Rheumatic Diseases