|
|
Home
Search
Study Topics
Glossary
|
 |
|
|
|
|
|
|
|
|
|
|
|
|
||||||||||||||||||||||||||||||||||||
| Sponsored by: |
Bayhill Therapeutics |
|---|---|
| Information provided by: | Bayhill Therapeutics |
| ClinicalTrials.gov Identifier: | NCT00453375 |
Purpose
The purpose of this study is to determine the safety of BHT-3021 injections given weekly for 12 weeks and to evaluate the effect of BHT-3021 on antibody and immune (T cell) responses to autoantigens (e.g. insulin). Changes in pancreatic beta cell function, insulin requirements and blood glucose levels will also be evaluated.
| Condition | Intervention | Phase |
|---|---|---|
|
Diabetes Hypoglycemia |
Drug: BHT-3021 Drug: BHT-Placebo |
Phase I |
| Study Type: | Interventional |
| Study Design: | Treatment, Randomized, Double Blind (Subject, Investigator), Placebo Control, Crossover Assignment, Safety Study |
| Official Title: | A Randomized, Blinded, Placebo Controlled, Safety and Pharmacodynamic Study of BHT-3021 With Open Label Cross-Over in Subjects With Type I Diabetes Mellitus |
| Estimated Enrollment: | 72 |
| Study Start Date: | October 2006 |
| Estimated Primary Completion Date: | December 2008 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
1: Experimental
BHT-3021
|
Drug: BHT-3021
Evaluation of up to four dose levels will be given in weekly IM injections for 12 weeks.
|
|
2: Placebo Comparator
BHT-Placebo
|
Drug: BHT-Placebo
Evaluation of up to four dose levels will be given in weekly IM injections for 12 weeks.
|
Type 1 diabetes results from an attack by the body's own immune system on the insulin producing cells in the pancreas. Around 80% of diagnosed patients have detectable antibodies to islet cell self-proteins including, insulin IA-2 and glutamic acid decarboxylase. The drug, BHT-3021 is being studied because an agent that stops autoimmune damage could offer patients benefit.
Study Description: A Randomized, Blinded, Placebo Controlled, Safety and Pharmacodynamic Study of BHT-3021 with Open Label Cross-Over in Subjects with Type I Diabetes Mellitus that will enroll up to 72 subjects in this trial. Subjects will be randomized to BHT-3021 or BHT-placebo in a 2:1 ratio.
The duration of the study is approximately 25 to 37 months depending on treatment assignment: 4 week Screening Period; 12 month Blinded Treatment and Evaluation Period; 12 month Cross-over Treatment and Evaluation Period (BHT-placebo subjects only); 12 month Long Term Follow-Up period.
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Inclusion Criteria
insulin, GAD-65, or IA-2
Exclusion Criteria:
Contacts and Locations| Contact: Kathryn A Woody | 650-320-2838 | kwoody@bayhilltx.com |
| United States, Alabama | |
| University of Alabama at Birmingham School of Medicine | Recruiting |
| Birmingham, Alabama, United States, 35294 | |
| Contact: Marianne Vetrano 205-934-4112 mvetrano@uab.edu | |
| Principal Investigator: Fernando Ovalle, MD | |
| United States, California | |
| Valley Research | Recruiting |
| Fresno, California, United States, 93720 | |
| Contact: Mike Guerrero, RN 559-261-0992 ext 19 | |
| Principal Investigator: Paul Norwood, MD | |
| United States, Colorado | |
| Barbara Davis Center for Childhood Diabetes | Recruiting |
| Aurora, Colorado, United States, 80045 | |
| Contact: Amy Wallace, MA 303-724-6768 amy.wallace@UCHSC.edu | |
| Principal Investigator: Peter Gottlieb, MD | |
| Private Practice | Recruiting |
| Denver, Colorado, United States, 80209 | |
| Contact: Judi Recht, RN 303-388-6410 ext 213 jrecht47@comcast.net | |
| Principal Investigator: Leonard Zemel, MD | |
| United States, District of Columbia | |
| MedStar Research Institute | Recruiting |
| Washington, District of Columbia, United States, 20003 | |
| Contact: Laurie Want, RN,MS 202-787-5376 Laurie.Want@Medstar.net | |
| Principal Investigator: Robert Ratner, MD | |
| United States, Florida | |
| University of Miami, Miller School of Medicine, Diabetes Research Institute | Recruiting |
| Miami, Florida, United States, 33136 | |
| Contact: Robert Agramonte, RN, BSN 305-243-6573 ragramon@u.med.miami.edu | |
| Principal Investigator: Jay Skyler, MD | |
| Private Practice | Recruiting |
| Wellington, Florida, United States, 33414 | |
| Contact: Debbie Hays, RN 561-641-7736 superfp@aol.com | |
| Principal Investigator: Richard Hays, BA, MD | |
| United States, Nebraska | |
| Creighton Diabetes Center | Recruiting |
| Omaha, Nebraska, United States, 68131 | |
| Contact: Benjamin Bumgarner 402-280-4324 bjb@creighton.edu | |
| Principal Investigator: Marc Rendell, MD | |
| United States, Texas | |
| Diabetes and Glandular Disease Center | Recruiting |
| San Antonio, Texas, United States, 78229 | |
| Contact: Ben Blaylock, RN 210-615-5565 ext 1607 bblaylock@dgdresearch.com | |
| Principal Investigator: Mark Kipnes, MD | |
| United States, Washington | |
| Benaroya Research Institute at Virginia Mason | Recruiting |
| Seattle, Washington, United States, 98101-2795 | |
| Contact: Heather Vendettuoli 206-233-6378 hventdettuoli@benaroyaresearch.org | |
| Principal Investigator: Carla Greenbaum, MD | |
| Australia, Queensland | |
| Peninsula Clinical Research Centre | Recruiting |
| Kippa Ring, Queensland, Australia, 4021 | |
| Contact: Gay Goodman +61 7 3889 5019 jstein@acro.net.au | |
| Principal Investigator: Vernon Heazlewood, MD | |
| Australia, Victoria | |
| Royal Melbourne Hospital | Recruiting |
| Parkville, Victoria, Australia, 3050 | |
| Contact: Lee-anne Lynch +61 3 9342 7278 Lee-Anne.Lynch@mh.org.au | |
| Principal Investigator: Peter Colman, MD | |
| Eastern Clinical Research Unit | Recruiting |
| Ringwood East, Victoria, Australia, 3050 | |
| Contact: Amy Clark +61 3 9871 3312 Amy.Clark@Easternhealth.org.au | |
| Principal Investigator: Murray Gerstman, MD | |
| Australia, Western Australia | |
| Fremantle Hospital | Recruiting |
| Fremantle, Western Australia, Australia, 6160 | |
| Contact: Michelle England +61 8 9431 3230 mengland@cyllene.uwa.edu.au | |
| Principal Investigator: Tim Davis, MD | |
| New Zealand, Auckland | |
| Middlemore Hospital | Recruiting |
| Otahuhu, Auckland, New Zealand, Private Bag 93311 | |
| Contact: Ruth Withers +64 9 276 0044 ext 2967 ruth.withers@middlemore.co.nz | |
| Principal Investigator: John Baker, MD | |
| New Zealand, Canterbury | |
| Christchurch Hospital | Recruiting |
| Christchurch, Canterbury, New Zealand, Private Bag 4710 | |
| Contact: Jinny Willis, MD +64 3 364 0448 Jinny.Willis@cdhb.govt.nz | |
| Principal Investigator: Russell Scott, MD | |
| New Zealand, Waikato | |
| Waikato Regional Diabetes Service | Recruiting |
| Hamilton, Waikato, New Zealand, Private bag 3200 | |
| Contact: Annie Johnstone + 64 7 839 8701 ext 6679 johnstoa@waikatodhb.govt.nz | |
| Principal Investigator: Peter Dunn, MD | |
| New Zealand, Wellington | |
| The Diabetes Centre | Recruiting |
| Newtown, Wellington, New Zealand, Private Bag 7902 | |
| Contact: Linda Kent + 64 4 918 6631 linda.kent@ccdhb.org.nz | |
| Principal Investigator: Jeremy Krebs, MD | |
| Study Chair: | Peter Gottlieb, MD | Barbara Davis Center for Childhood Diabetes |
| Study Director: | Frank H Valone, MD | Bayhill Therapeutics Inc. |
| Study Chair: | Len Harrison, MD | Walter and Eliza Hall Institute of Medical Research |
More Information
| Responsible Party: | Bayhill Therapeutics ( Kathryn Woody, Clinical Trials Manager ) |
| Study ID Numbers: | BHT-3021-01 |
| Study First Received: | March 26, 2007 |
| Last Updated: | June 10, 2008 |
| ClinicalTrials.gov Identifier: | NCT00453375 History of Changes |
| Health Authority: | United States: Food and Drug Administration |
|
Diabetic Diabetes Type 1 Diabetes Type 1 Diabetes Mellitus autoimmune disease |
|
Metabolic Diseases Autoimmune Diseases Diabetes Mellitus, Type 1 Diabetes Mellitus Endocrine System Diseases |
Diabetes Mellitus Type 1 Endocrinopathy Glucose Metabolism Disorders Hypoglycemia Metabolic Disorder |
|
Autoimmune Diseases Metabolic Diseases Immune System Diseases Diabetes Mellitus, Type 1 |
Diabetes Mellitus Endocrine System Diseases Glucose Metabolism Disorders Hypoglycemia |
