Phase 2
N=253
Evaluation of the Allergenicity of AMPHADASE INJECTION (Hyaluronidase Injection USP)
Allergic Skin Reaction
Bottom Line
View on ClinicalTrials.gov: NCT01689363 ↗Enrolled (actual)
253
Serious AEs
0.0%
Results posted
Jan 2017
Primary outcome: Primary: Positive Allergic Reaction to Amphadase® in the Per-Protocol Population (PPP) — 0 participants
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 2
- Interventions
- Hyaluronidase (Drug); Histamine (Drug); Saline (Drug)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Amphastar Pharmaceuticals, Inc.
- Primary completion
- Nov 2012
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Positive Allergic Reaction to Amphadase® in the Per-Protocol Population (PPP) |
— | — |
| PRIMARY Positive Allergic Reaction to Amphadase® in the Intent-to-Treat Population (ITT) |
7 | — |
| SECONDARY Observed Wheal Size in the Per-Protocol Population (PPP) |
1.1; 1.7; 15.3 | — |
| SECONDARY Observed Erythema Size in the Per-Protocol Population (PPP) |
4.3; 0.6; 44.4 | — |
| SECONDARY Allergic Wheal Size in the Per-Protocol Population (PPP) |
0.1; 0.0; 15.2 | — |
| SECONDARY Allergic Erythema Size in the Per-Protocol Population (PPP) |
1.1; 0.0; 44.1 | — |
| SECONDARY Local Itchiness Rate in the Per-Protocol Population (PPP) |
7.7; 1.1; 100.0 | — |
| SECONDARY Erythema Responder Rate in the Per-Protocol Population (PPP) |
51.4; 8.7; 100.0 | — |
| SECONDARY Observed Wheal Size in the Intent-to-Treat Population (ITT) |
1.5; 1.7; 14.1 | — |
| SECONDARY Observed Erythema Size in the Intent-to-Treat Population (ITT) |
5.4; 0.9; 41.5 | — |
| SECONDARY Allergic Erythema Size in the Intent-to-Treat Population (ITT) |
2.1; 0.1; 34.0 | — |
| SECONDARY Local Itchiness Rate in the Intent-to-Treat Population (ITT) |
10.3; 1.6; 79.1 | — |
| SECONDARY Erythema Responder Rate in the Intent-to-Treat Population (ITT) |
53.8; 11.1; 97.6 | — |
| SECONDARY Allergic Wheal Size in the Intent-to-Treat Population (ITT) |
0.5; 0.0; 11.5 | — |
Summary
This study is designed to evaluate the allergenicity of Amphadase® in healthy volunteers using an intradermal skin test.
Eligibility Criteria
Inclusion Criteria
Healthy volunteers of either gender; Those without clinically significant cardiovascular gastrointestinal, hepatic, neurological, psychiatric, endocrine, or other major systemic disease that would unduly risk the subject's safety or interfere with the interpretation of results, assessed according to the judgment of the Principal Investigator. A non-inclusive list which would not be exclusionary and define healthy individual for the purposes of this study are:
- hypothyroidism,
- stable hypertension except those subjects on beta blockers including ocular preparations,
- seasonal/perennial allergic rhinitis if able to wash out of antihistamines,
- stable, mild intermittent asthma (subjects using beta agonists as a monotherapy on an as-needed basis, excluding daily usage),
- migraine if not taking excluded medications,
- mild anxiety/depression if not taking excluded medications, and
- mild arthritic conditions if not taking excluded medications.
- Willingness and ability to sign an informed consent document;
- 18 - 80 years of age;
- Intact skin at the forearm ;
- Female participants are currently practicing effective birth control methods or abstinence.
Exclusion Criteria
- Known allergy, hypersensitivity or contraindications to hyaluronidase, thimerosal, edetate disodium (EDTA);
- Use of medications within a duration considered to interfere with skin testing.
- Known dermographism which may interfere with skin testing.
- Pregnant or lactating women.
Data sourced from ClinicalTrials.gov (NCT01689363). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.