Study of a Large Protein Molecule Administered With Escalating Doses of Recombinant Human Hyaluronidase

This study has been completed.
Sponsor:
Information provided by:
Halozyme Therapeutics
ClinicalTrials.gov Identifier:
NCT00369187
First received: August 25, 2006
Last updated: January 7, 2008
Last verified: January 2008
  Purpose

This Phase IV, dose escalation, within-patient controlled study of pharmacokinetics (PK), safety and tolerability compares a single dose administration of a large protein molecule without recombinant human hyaluronidase (rHuPH20) to a single dose administration of the large molecule with escalating doses of rHuPH20. The study hypothesizes that an optimal dose of rHuPH20 will increase the bioavailability of large molecule drug administration.


Condition Intervention Phase
Rheumatoid Arthritis
Drug: large protein molecule
Phase 4

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Pharmacokinetics Study
Intervention Model: Crossover Assignment
Masking: Open Label
Primary Purpose: Treatment

Resource links provided by NLM:


Further study details as provided by Halozyme Therapeutics:

Primary Outcome Measures:
  • AUC

Secondary Outcome Measures:
  • Tmax, Cmax, half-lives, injection site reactions, safety and tolerability, NAbs

Estimated Enrollment: 15
Study Start Date: July 2006
Study Completion Date: October 2006
Detailed Description:

Sequential enrollment into four rHuPH20 dose cohorts.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. Males or females at least 18 years of age with RA treated with MTX who have been treated with:

    • co-injected large molecule protein for at least two cycles, and
    • have had stable disease with no symptom flares in the previous 30 days.
  2. AST (SGOT) and ALT (SGPT) within normal range within 7 days prior to entry in the study.
  3. Adequate venous access in at least one extremity.
  4. A negative pregnancy test (if female of child-bearing potential) within 7 days prior to entry in the study.
  5. Decision-making capacity.
  6. Signed, written IRB-approved informed consent.

Exclusion Criteria:

  1. Unacceptable toxicity to the large molecule protein, or contraindication to or other reason to not continue the large molecule protein per the package insert (e.g., active or latent tuberculosis, chronic or localized infections, or concurrent treatment with anakinra).
  2. History of active tuberculosis, or known positive tuberculin skin test unless the patient has successfully completed a nine-month course of isoniazid therapy.
  3. Concurrent use of any disease-modifying anti-rheumatic drug except the large molecule protein and MTX.
  4. Any anticipation that the dose of the large molecule protein or MTX would be changed within 4 weeks following entry in the study.
  5. Known allergy to hyaluronidase or any hyaluronidase product.
  6. Known allergy to bee or vespid venom.
  7. Contraindication to IV heparin lock or known hypersensitivity to heparin.
  8. Edema, infection, or any other lower extremity or pelvic disorder that might affect subcutaneous absorption from the thigh.
  9. Presence of any other medical condition that would present an unacceptable safety risk to the patient.
  10. Participation in a study of any investigational drug or device within 30 days of enrollment in this study.
  Contacts and Locations
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, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00369187

Sponsors and Collaborators
Halozyme Therapeutics
Investigators
Principal Investigator: Malin Prupas, M.D. Arthritic Center of Reno
  More Information

No publications provided

ClinicalTrials.gov Identifier: NCT00369187     History of Changes
Other Study ID Numbers: HZ2-06-02
Study First Received: August 25, 2006
Last Updated: January 7, 2008
Health Authority: United States: Food and Drug Administration

Additional relevant MeSH terms:
Arthritis
Arthritis, Rheumatoid
Joint Diseases
Musculoskeletal Diseases
Rheumatic Diseases
Connective Tissue Diseases
Autoimmune Diseases
Immune System Diseases

ClinicalTrials.gov processed this record on August 01, 2014