AP-011 Study to Evaluate the Safety of a Single Intra-articular Injection of Ampion™ for Arthritis of the Basal Thumb Joint

A

Ampio Pharmaceuticals

Status and phase

Completed
Phase 1

Conditions

Osteoarthritis of the Hand

Treatments

Biological: Saline
Biological: AMPION™

Study type

Interventional

Funder types

Industry

Identifiers

NCT02762760
AP-011

Details and patient eligibility

About

This study will evaluate the safety of an intra-articular injection of AMPION™ in adults with pain due to osteoarthritis of the basal thumb joint.

Full description

A prospective phase I study to evaluate the safety of a single intra-articular injection of Ampion™ as a treatment for arthritis of the basal thumb joint. Primary Objective is: To evaluate the safety of Ampion™ (up to 3 mL) in comparison to saline placebo (up to 3 mL) when injected into the basal thumb joint.

Enrollment

15 patients

Sex

All

Ages

40 to 85 years old

Volunteers

No Healthy Volunteers

Inclusion 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).
  • Radiographic evidence of Basal joint arthritis (Eaton-Littler classification, stages 1 through 4).
  • Pain associated with basal joint arthritis, defined as a score ≥ 4 as evaluated by the Australian-Canadian OA Index (AUSCAN)-numeric rating score (NRS, 0-10).

Exclusion criteria

  • As a result of medical review and screening investigation, the Principal Investigator considers the subject unfit for the study.
  • Previous Ampion™ injection.
  • 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).
  • Women who are currently pregnant or who could become pregnant.
  • Inflammatory or crystal arthropathies, acute fractures, history of aseptic necrosis, as assessed locally by the Principal Investigator.
  • Any other disease or condition interfering with the free use and evaluation of the index thumb for the duration of the trial (e.g., congenital defects, stricture).
  • Major injury to the index thumb within the 12 months prior to screening.
  • Any pharmacological or non-pharmacological treatment targeting OA started or changed during the 4 weeks prior to treatment or likely to be changed during the duration of the study.

Use of the following medications are exclusionary:

  • IA injected pain medications in the study thumb during the study;
  • Analgesics containing opioids;
  • NSAIDs (including but not limited to ibuprofen, aspirin, naproxen, diclofenac) acetaminophen is available as a rescue medication during the study from the provided supply;
  • Topical prescription treatment on osteoarthritis index thumb during the study;
  • Significant anticoagulant therapy (e.g., Heparin or Lovenox) during the study (treatment such as Aspirin in the cardio-protective dose (81mg) and Plavix are allowed);
  • Systemic treatments that may interfere with safety or efficacy assessments during the study;
  • Immunosuppressants;
  • Use of corticosteroids > 10 mg prednisolone equivalent per day (if ≤ 10 mg prednisolone, the dose must be stable, defined as chronic use of the same dose for at least 1 month).
  • Any human albumin treatment in the 3 months before randomization.

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Quadruple Blind

15 participants in 2 patient groups

AMPION™
Experimental group
Description:
AMPION™, up to 3 mL, single intra-articular injection. Ampion is the ultrafiltrate of 5% HSA.
Treatment:
Biological: AMPION™
Saline
Experimental group
Description:
Saline placebo, up to 3 mL, single intra-articular injection. Saline used as the comparator is 0.9% Sodium Chloride
Treatment:
Biological: Saline

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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