Search / Trial NCT00002073

A Double-Blind, Placebo-Controlled Study With Open-Label Follow-Up To Determine the Safety and Efficacy of Subcutaneous Doses of r-HuEPO in AIDS Patients With Anemia Induced by Their Disease and AZT Therapy

Launched by ORTHO PHARMACEUTICALS · Aug 30, 2001

Trial Information

Current as of December 06, 2024

Completed

Keywords

Recombinant Proteins Injections, Subcutaneous Erythropoietin Acquired Immunodeficiency Syndrome Anemia Zidovudine

ClinConnect Summary

No description provided

Gender

ALL

Eligibility criteria

  • Inclusion Criteria
  • Concurrent Medication:
  • Allowed:
  • Maintenance dose of zidovudine (AZT) of at least 400 mg daily.
  • Exclusion Criteria
  • Co-existing Condition:
  • Patients with the following are excluded:
  • History of any primary hematologic disease.
  • Clinically significant disease / dysfunction of the pulmonary, cardiovascular, endocrine, neurologic, gastrointestinal, or genitourinary systems not attributable to underlying AIDS.
  • AIDS-related dementia.
  • Uncontrolled hypertension (diastolic blood pressure \> 100 mmHg).
  • Presence of concomitant iron deficiency.
  • Anemia attributable to factors other than AIDS or zidovudine (AZT) therapy.
  • Acute opportunistic infection.
  • History of seizures.
  • Patients with clinically significant disease / dysfunction of the pulmonary, cardiovascular, endocrine, neurologic, gastrointestinal, or genitourinary systems not attributable to underlying AIDS are excluded.
  • Must not have previously participated in any other r-HuEPO clinical studies.
  • Prior Medication:
  • Excluded within 30 days of study entry:
  • Experimental drug or experimental device.
  • Cytotoxic chemotherapy.
  • * Excluded within 2 months of study entry:
  • Androgen therapy.
  • Clinical diagnosis of AIDS and related anemia.
  • Clinical diagnosis of AIDS.
  • Clinically stable for 1 month preceding study entry.
  • Maintenance dose of zidovudine (AZT) of at least 400 mg daily.
  • Substance abuse.

About Ortho Pharmaceuticals

Ortho Pharmaceuticals is a leading healthcare company specializing in innovative solutions for women's health and reproductive medicine. With a commitment to advancing patient care through research and development, Ortho Pharmaceuticals focuses on delivering effective and safe pharmaceutical products. The organization is dedicated to conducting rigorous clinical trials that uphold the highest ethical standards, aiming to enhance treatment options and improve health outcomes for women globally. Through collaboration with healthcare professionals and patients, Ortho Pharmaceuticals strives to address unmet medical needs and foster advancements in the field of women's health.

Locations

Raritan, New Jersey, United States

People applied

Timeline

First submit

Trial launched

Trial updated

Estimated completion

Not reported

Discussion 0

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