Equivalence Study of Tuberculin Purified Protein Derivative in Comparison With a Reference Standard (PPD-S2)

Tuberculosis Identification. Clinical Trial

— 02  

Official title:

A Randomized, Double-blind, Equivalence Study of Tuberculin Purified Protein Derivative in Comparison With a Reference Standard Tuberculin Purified Protein Derivative (PPD-S2) for Detection of Tuberculosis in Subjects With a Confirmed Diagnosis of Tuberculosis.

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT01798121
• Other study ID #: JHP-Aplisol-02
• Status: Not yet recruiting
• Phase: Phase 2
• First received: January 31, 2013
• Last updated: February 21, 2013
• Start date: February 2013
• Est. completion date: July 2013

Study information

• Verified date: February 2013
• Source: JHP Pharmaceuticals LLC
• Contact: Arlene Lund, B.Sc.
• Phone: 919-985-3220
• Email: arlene.lund[@]incresearch.com
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial Summary

A study to determine bioequivalence of PPD material versus Reference Standard.

Description:

This study is a multicenter, double-blind, active-controlled parallel-group study to determine the bioequivalence of newly produced PPD material versus PPD-S2 in the detection of male and female subjects with current or previously diagnosed intrathoracic Mtb infection, as documented by a positive culture for Mtb (preferred method), by their primary care or attending physician and/or by the subject's current or prior medical records (ie, sensitivity determination).

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 90
• Est. completion date: July 2013
• Est. primary completion date: March 2013
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 18 Years to 60 Years

Eligibility

Inclusion Criteria:

1. Males or nonpregnant females age 18 to 60 years

2. Documented PPD reactivity of 5 to 21 mm in the past, documented in a medical record. Self-reported PPD reactivity will be acc

3. Give written informed consent to participate

4. Generally healthy, as determined by medical history and targeted physical examination, if indicated

5. Possess 2 forearms that are free of burns, scars, eczema, or any physical deformity, which could impair injection of study prepar

6. Comprehension of the study requirements; expressed availability for the required study period, including readings at the nomina

Exclusion Criteria:

1. Prior PPD test within the past 30 days

2. Subject is of childbearing potential and unable to use contraceptives; is planning pregnancy; is pregnant or lactating

3. History of anaphylactic reaction, severe positive tuberculin reaction (eg, ulceration, necrosis) or other severe reaction to PPD in

4. Subject received a Bacillus Calmette-Guérin (BCG) vaccination in the past, or was born or lived outside the US as a child and is

5. Presence of conditions that may suppress TST reactivity -

Study Design

Allocation: Randomized, Endpoint Classification: Bio-equivalence Study, Intervention Model: Single Group Assignment, Masking: Double Blind (Subject, Investigator)

Related Conditions & MeSH terms

• Tuberculosis
• Tuberculosis Identification.

Intervention

Biological:
• To compare new PPD to reference standard material
Aplisol@ will be compared to reference standard material
• Reference standard
Response of reference standard material compared to Aplisol@.

Locations

Country	Name	City	State
n/a

Sponsors (2)

Lead Sponsor	Collaborator
JHP Pharmaceuticals LLC	INC Research

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Compare new PPD to Reference Standard	Determine bio-equivalence of material used in trial by means of dose response and reaction sizes in patients.	72 hours	No