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CompletedNCT01735617Updated May 17, 2017Results posted

Pilot Study to Characterize and Examine the Pharmacokinetics and Efficacy of Chronocort® in Adults With CAH

A Phase 2 interventional study of Hydrocortisone Modified Release Capsules in Endocrine Disease, Adrenal Insufficiency and Congenital Adrenal Hyperplasia, sponsored by Neurocrine UK Limited. Completed at 1 site in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2017-05-17.

Sponsored by Neurocrine UK Limited · Phase 2, Interventional, and Treatment

Phase
Phase 2
Study type
Interventional
Enrollment
16
Allocation
Not applicable
Ages
18 Years and older
Sex
All
01

Study summary

The purpose of this study is to gather safety and effectiveness information about a new formulation of Hydrocortisone (Chronocort®) used to treat patients with a disease called congenital adrenal hyperplasia (CAH). Hydrocortisone is the man-made version of the hormone cortisol, which is released in the body following a regular daily pattern. The objective of the study is to measure the levels of hydrocortisone that are absorbed into the bloodstream once Chronocort® is taken and what affects it has on other hormones in the body. Since Chronocort® is anticipated to mimic the same release pattern of cortisol in the body, it is hoped that patients with CAH will be treated more effectively to manage their disease.

Read the detailed description

This study is a Phase 2 pilot study to characterize and examine the pharmacokinetics and efficacy profile of Chronocort® in adults with congenital adrenal hyperplasia (CAH). It is designed as a two-part, single cohort, open label, multiple dose Phase 2 pilot study to: (Part A) characterize and examine the pharmacokinetics (PK) and disease bio-marker behavior following short-term dosing with Chronocort®; and to (Part B) examine the disease control after six months dose titration with Chronocort® in adults with CAH.

02

Conditions studied

  • Endocrine Disease
  • Adrenal Insufficiency
  • Congenital Adrenal Hyperplasia

Keywords

  • congenital adrenal hyperplasia
  • glucocorticoids
  • cortisol
  • adrenal
03

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

Inclusion criteria

  1. Known CAH due to 21-hydroxylase deficiency (classic CAH) based on hormonal and genetic testing currently treated with hydrocortisone, prednisone, prednisolone or dexamethasone on a stable dosage for a minimum of 3 months.
  2. Male or female patients aged 18 and above.
  3. Provision of signed written informed consent.
  4. Good general health.
  5. Females of childbearing potential must have a negative pregnancy test initially and at all visits. Females who are engaging in sexual intercourse must be using a medically acceptable method of contraception (as defined in the protocol, section 10.5).
  6. Plasma renin activity must be within the clinically acceptable range at screening (less than 1.5 times upper normal range).

Exclusion criteria

Exclusion Criteria:

  1. Co-morbid condition requiring daily administration of a medication that induces hepatic enzymes or interferes with the metabolism of glucocorticoids.
  2. Clinical or biochemical evidence of hepatic or renal disease. Creatinine above the normal range or elevated liver function tests (ALT or AST) > 2 times the upper limits of normal.
  3. Females who are pregnant or lactating.
  4. Women taking an estrogen-containing oral contraceptive pill and who have taken it within 6 weeks of recruitment.
  5. Patients taking spironolactone.
  6. Patients on inhaled or oral steroids apart from treatment for CAH.
  7. Patients with any other significant medical or psychiatric conditions that in the opinion of the Investigator would preclude participation in the trial.
  8. Participation in another clinical trial of an investigational or licensed drug or device within the 3 months prior to inclusion in this study.
  9. Patients with history of bilateral adrenalectomy.
04

Study design

Phase
Phase 2
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrollment
16 participants (actual)

Study arms

  • Experimental
    Hydrocortisone Modified Release Capsules

    Chronocort Modified Release Capsules, 5mg, 10mg and 20mg Dosing frequency twice-daily (mane and nocte) Dose setting by titration to achieve optimal biochemical and therapeutic response

    Drug: Hydrocortisone Modified Release Capsules

Interventions

  • DrugHydrocortisone Modified Release Capsules

    Patients with congenital adrenal hyperplasia standardised on conventional therapy is enrolled onto the study and treatment is switched to Chronocort, initially for pharmacokinetic assessment followed by longer-term biochemical and efficacy assessment

    Also known as: Chronocort

05

What researchers measure

Primary outcomes

  1. Pharmacokinetic Profile (Cmax) Following Short-term Treatment With Chronocort® in Adult Patients With Congenital Adrenal Hyperplasia

    The maximum plasma concentration (Cmax) of chronocort

    Time frame: 24 hours

  2. Pharmacokinetic Profile (AUC0-24) Following Short-term Treatment With Chronocort® in Adult Patients With Congenital Adrenal Hyperplasia

    Area under the curve (AUC) from 0 to 24 hours (sampling occurs at the following timepoints: 2300, 0100, 0300, 0500, 0600, 0700, 0800, 0900, 1000, 1100, 1200, 1300, 1400, 1500, 1600, 1700, 1900, 2100, 2300hrs)

    Time frame: 24 hours (at 2300, 0100, 0300, 0500, 0600, 0700, 0800, 0900, 1000, 1100, 1200, 1300, 1400, 1500, 1600, 1700, 1900, 2100, 2300hrs)

  3. Pharmacokinetic Profile (Tmax) Following Short-term Treatment With Chronocort® in Adult Patients With Congenital Adrenal Hyperplasia

    Time to maximum plasma concentration (tmax)

    Time frame: 24 hours

Secondary outcomes

  1. The Percentage of Patients With 17-OHP and Androstenedione Levels at 0700h Within Proposed Optimal Ranges Whilst on Chronocort and Whilst on Standard Therapy (at Baseline)

    Proposed optimal ranges of 17-OHP: 300-1200ng/dl Proposed optimal ranges of androstenedione: 40-150ng.dl for males and 30-200ng/dl for females

    Time frame: Specific time point (0700hrs)

  2. 17-OHP Levels at 0700h, 1700h and 2300h

    17-OHP levels at 0700h, 1700h and 2300h

    Time frame: Specified time points (0700h, 1700h and 2300h)

  3. Androstenedione Levels at 0700h, 1700h and 2300h

    Androstenedione levels at 0700h, 1700h and 2300h

    Time frame: Specified time points (0700h, 1700h and 2300h)

  4. ACTH Levels at 0700h, 1700h and 2300h

    ACTH levels at 0700h, 1700h and 2300h

    Time frame: Specified time points (0700h, 1700h and 2300h)

  5. AUC Values (Nmol*h/L) for Androstenedione

    AUC values (nmol\*h/L) for Androstenedione for the following reporting periods: 24 hours (2300-2300h), 2300-0700h, 0700-1500h and 1500-2300h

    Time frame: Specific time points (2300-2300h, 2300-0700h, 0700-1500h and 1500-2300h)

  6. AUC Values (Nmol*h/L) for 17-OHP

    AUC values (nmol\*h/L) for 17-OHP for the following reporting periods: 24 hours (2300-2300h), 2300-0700h, 0700-1500h and 1500-2300h

    Time frame: Specific time points (2300-2300h, 2300-0700h, 0700-1500h and 1500-2300h)

  7. AUC Values (Pmol*h/L) for ACTH

    AUC values (pmol\*h/L) for ACTH for the following reporting periods: 24 hours (2300-2300h), 2300-0700h, 0700-1500h and 1500-2300h

    Time frame: Specific time points (2300-2300h, 2300-0700h, 0700-1500h and 1500-2300h)

06

Results

Posted May 17, 2017

Participant flow

Participant flow — Overall Study
MilestoneHydrocortisone Modified Release Capsules
Started16
Completed16
Not completed0

Outcome measures

PrimaryPharmacokinetic Profile (Cmax) Following Short-term Treatment With Chronocort® in Adult Patients With Congenital Adrenal Hyperplasia

The maximum plasma concentration (Cmax) of chronocort

Time frame:
24 hours
Reported as:
Mean · nmol/L
Pharmacokinetic Profile (Cmax) Following Short-term Treatment With Chronocort® in Adult Patients With Congenital Adrenal Hyperplasia
nmol/LChronocort
Pharmacokinetic Profile (Cmax) Following Short-term Treatment With Chronocort® in Adult Patients With Congenital Adrenal Hyperplasia601.213 ± 114.5987
Statistical analysis
  • Chronocort · Geometric means: 563.38
PrimaryPharmacokinetic Profile (AUC0-24) Following Short-term Treatment With Chronocort® in Adult Patients With Congenital Adrenal Hyperplasia

Area under the curve (AUC) from 0 to 24 hours (sampling occurs at the following timepoints: 2300, 0100, 0300, 0500, 0600, 0700, 0800, 0900, 1000, 1100, 1200, 1300, 1400, 1500, 1600, 1700, 1900, 2100, 2300hrs)

Time frame:
24 hours (at 2300, 0100, 0300, 0500, 0600, 0700, 0800, 0900, 1000, 1100, 1200, 1300, 1400, 1500, 1600, 1700, 1900, 2100, 2300hrs)
Reported as:
Mean · h*nmol/L
Pharmacokinetic Profile (AUC0-24) Following Short-term Treatment With Chronocort® in Adult Patients With Congenital Adrenal Hyperplasia
h*nmol/LChroncort
Pharmacokinetic Profile (AUC0-24) Following Short-term Treatment With Chronocort® in Adult Patients With Congenital Adrenal Hyperplasia5027.641 ± 1247.8425
PrimaryPharmacokinetic Profile (Tmax) Following Short-term Treatment With Chronocort® in Adult Patients With Congenital Adrenal Hyperplasia

Time to maximum plasma concentration (tmax)

Time frame:
24 hours
Reported as:
Mean · Hours
Pharmacokinetic Profile (Tmax) Following Short-term Treatment With Chronocort® in Adult Patients With Congenital Adrenal Hyperplasia
HoursChronocort
Pharmacokinetic Profile (Tmax) Following Short-term Treatment With Chronocort® in Adult Patients With Congenital Adrenal Hyperplasia7.9 ± 2.9
SecondaryThe Percentage of Patients With 17-OHP and Androstenedione Levels at 0700h Within Proposed Optimal Ranges Whilst on Chronocort and Whilst on Standard Therapy (at Baseline)

Proposed optimal ranges of 17-OHP: 300-1200ng/dl Proposed optimal ranges of androstenedione: 40-150ng.dl for males and 30-200ng/dl for females

Time frame:
Specific time point (0700hrs)
Reported as:
Number · percentage of participants
The Percentage of Patients With 17-OHP and Androstenedione Levels at 0700h Within Proposed Optimal Ranges Whilst on Chronocort and Whilst on Standard Therapy (at Baseline)
percentage of participantsHydrocortisone Modified Release Capsules
17-OHP (baseline)0
17-OHP (final visit)12.5
Androstenedione (baseline)56.3
Androstenedione (final visit)81.3
Secondary17-OHP Levels at 0700h, 1700h and 2300h

17-OHP levels at 0700h, 1700h and 2300h

Time frame:
Specified time points (0700h, 1700h and 2300h)
Reported as:
Mean · nmol/L
17-OHP Levels at 0700h, 1700h and 2300h
nmol/LHydrocortisone Modified Release Capsules
17-OHP: Part A, Days 1-2 (0700h)76.97 ± 91.986
17-OHP: Part A, Days 1-2 (1700h)70.99 ± 104.106
17-OHP: Part A, Days 1-2 (2300h)55.35 ± 93.632
17-OHP: Part A, Days 4-5 (0700h)7.72 ± 8.231
17-OHP: Part A, Days 4-5 (1700h)23.55 ± 66.046
17-OHP: Part A, Days 4-5 (2300h)27.27 ± 55.140
17-OHP: Part B, Visit 2 (0700h)24.86 ± 54.086
17-OHP: Part B, Visit 2 (1700h)15.17 ± 20.400
17-OHP: Part B, Visit 2 (2300h)26.65 ± 51.185
17-OHP: Part B, Visit 3 (0700h)34.87 ± 49.072
17-OHP: Part B, Visit 3 (1700h)13.81 ± 20.700
17-OHP: Part B, Visit 3 (2300h)18.95 ± 28.276
17-OHP: Part B, Visit 4 (0700h)13.67 ± 19.091
17-OHP: Part B, Visit 4 (1700h)34.70 ± 69.876
17-OHP: Part B, Visit 4 (2300h)22.19 ± 46.826
SecondaryAndrostenedione Levels at 0700h, 1700h and 2300h

Androstenedione levels at 0700h, 1700h and 2300h

Time frame:
Specified time points (0700h, 1700h and 2300h)
Reported as:
Mean · nmol/L
Androstenedione Levels at 0700h, 1700h and 2300h
nmol/LHydrocortisone Modified Release Capsules
Androstenedione: Part A, Days 1-2 (0700h)7.92 ± 8.474
Androstenedione: Part A, Days 1-2 (1700h)7.54 ± 7.966
Androstenedione: Part A, Days 1-2 (2300h)7.43 ± 9.388
Androstenedione: Part A, Days 4-5 (0700h)3.11 ± 2.178
Androstenedione: Part A, Days 4-5 (1700h)4.62 ± 8.005
Androstenedione: Part A, Days 4-5 (2300h)5.37 ± 8.340
Androstenedione: Part B, Visit 2 (0700h)4.96 ± 6.731
Androstenedione: Part B, Visit 2 (1700h)3.47 ± 3.094
Androstenedione: Part B, Visit 2 (2300h)3.79 ± 3.748
Androstenedione: Part B, Visit 3 (0700h)4.57 ± 3.561
Androstenedione: Part B, Visit 3 (1700h)3.61 ± 2.713
Androstenedione: Part B, Visit 3 (2300h)3.91 ± 3.103
Androstenedione: Part B, Visit 4 (0700h)3.40 ± 1.973
Androstenedione: Part B, Visit 4 (1700h)4.19 ± 4.602
Androstenedione: Part B, Visit 4 (2300h)3.37 ± 2.655
SecondaryACTH Levels at 0700h, 1700h and 2300h

ACTH levels at 0700h, 1700h and 2300h

Time frame:
Specified time points (0700h, 1700h and 2300h)
Reported as:
Mean · pmol/L
ACTH Levels at 0700h, 1700h and 2300h
pmol/LHydrocortisone Modified Release Capsules
ACTH: Part A, Days 1-2 (0700h)21.06 ± 29.767
ACTH: Part A, Days 1-2 (1700h)20.93 ± 30.121
ACTH: Part A, Days 1-2 (2300h)7.75 ± 9.873
ACTH: Part A, Days 4-5 (0700h)4.16 ± 9.190
ACTH: Part A, Days 4-5 (1700h)4.71 ± 7.382
ACTH: Part A, Days 4-5 (2300h)7.37 ± 7.990
ACTH: Part B, Visit 2 (0700h)7.02 ± 12.159
ACTH: Part B, Visit 2 (1700h)5.57 ± 6.769
ACTH: Part B, Visit 2 (2300h)8.66 ± 14.637
ACTH: Part B, Visit 3 (0700h)9.66 ± 12.418
ACTH: Part B, Visit 3 (1700h)4.71 ± 6.331
ACTH: Part B, Visit 3 (2300h)6.04 ± 7.997
ACTH: Part B, Visit 4 (0700h)12.18 ± 29.911
ACTH: Part B, Visit 4 (1700h)13.66 ± 22.851
ACTH: Part B, Visit 4 (2300h)9.44 ± 17.474
SecondaryAUC Values (Nmol*h/L) for Androstenedione

AUC values (nmol\*h/L) for Androstenedione for the following reporting periods: 24 hours (2300-2300h), 2300-0700h, 0700-1500h and 1500-2300h

Time frame:
Specific time points (2300-2300h, 2300-0700h, 0700-1500h and 1500-2300h)
Reported as:
Mean · nmol*h/L
AUC Values (Nmol*h/L) for Androstenedione
nmol*h/LHydrocortisone Modified Release Capsules
Androstenedione: Part A, Days 1-2 AUC (2300-2300h)166.19 ± 171.969
Androstenedione: Part A, Days 1-2 AUC (2300-0700h)41.42 ± 34.133
Androstenedione: Part A, Days 1-2 AUC (0700-1500h)65.33 ± 76.337
Androstenedione: Part A, Days 1-2 AUC (1500-2300h)59.44 ± 65.995
Androstenedione: Part A, Days 4-5 AUC (2300-2300h)104.37 ± 128.725
Androstenedione: Part A, Days 4-5 AUC (2300-0700h)36.02 ± 40.225
Androstenedione: Part A, Days 4-5 AUC (0700-1500h)32.01 ± 31.503
Androstenedione: Part A, Days 4-5 AUC (1500-2300h)37.91 ± 58.394
Androstenedione: Part B, Visit 2 AUC (2300-2300h)88.58 ± 86.364
Androstenedione: Part B, Visit 2 AUC (2300-0700h)35.12 ± 43.580
Androstenedione: Part B, Visit 2 AUC (0700-1500h)26.07 ± 22.298
Androstenedione: Part B, Visit 2 AUC (1500-2300h)27.39 ± 23.989
Androstenedione: Part B, Visit 3 AUC (2300-2300h)91.46 ± 65.295
Androstenedione: Part B, Visit 3 AUC (2300-0700h)33.25 ± 26.255
Androstenedione: Part B, Visit 3 AUC (0700-1500h)27.92 ± 16.297
Androstenedione: Part B, Visit 3 AUC (1500-2300h)30.30 ± 26.188
Androstenedione: Part B, Visit 4 AUC (2300-2300h)86.27 ± 70.892
Androstenedione: Part B, Visit 4 AUC (2300-0700h)29.09 ± 23.314
Androstenedione: Part B, Visit 4 AUC (0700-1500h)27.03 ± 20.009
Androstenedione: Part B, Visit 4 AUC (1500-2300h)30.13 ± 28.797
SecondaryAUC Values (Nmol*h/L) for 17-OHP

AUC values (nmol\*h/L) for 17-OHP for the following reporting periods: 24 hours (2300-2300h), 2300-0700h, 0700-1500h and 1500-2300h

Time frame:
Specific time points (2300-2300h, 2300-0700h, 0700-1500h and 1500-2300h)
Reported as:
Mean · nmol*h/L
AUC Values (Nmol*h/L) for 17-OHP
nmol*h/LHydrocortisone Modified Release Capsules
17-OHP: Part A, Days 1-2 AUC 2300-2300h1407.83 ± 1829.291
17-OHP: Part A, Days 1-2 AUC 2300-0700h243.99 ± 339.580
17-OHP: Part A, Days 1-2 AUC 0700-1500h607.74 ± 805.822
17-OHP: Part A, Days 1-2 AUC 1500-2300h556.11 ± 769.492
17-OHP: Part A, Days 4-5 AUC 2300-2300h446.90 ± 817.074
17-OHP: Part A, Days 4-5 AUC 2300-0700h169.83 ± 268.178
17-OHP: Part A, Days 4-5 AUC 0700-1500h91.53 ± 147.801
17-OHP: Part A, Days 4-5 AUC 1500-2300h190.73 ± 425.505
17-OHP: Part B, Visit 2 AUC 2300-2300h395.65 ± 587.533
17-OHP: Part B, Visit 2 AUC 2300-0700h168.01 ± 337.666
17-OHP: Part B, Visit 2 AUC 0700-1500h82.41 ± 91.708
17-OHP: Part B, Visit 2 AUC 1500-2300h145.24 ± 215.115
17-OHP: Part B, Visit 3 AUC 2300-2300h432.02 ± 393.897
17-OHP: Part B, Visit 3 AUC 2300-0700h152.63 ± 144.576
17-OHP: Part B, Visit 3 AUC 0700-1500h139.21 ± 147.353
17-OHP: Part B, Visit 3 AUC 1500-2300h140.18 ± 182.786
17-OHP: Part B, Visit 4 AUC 2300-2300h436.54 ± 678.052
17-OHP: Part B, Visit 4 AUC 2300-0700h101.33 ± 148.003
17-OHP: Part B, Visit 4 AUC 0700-1500h120.32 ± 172.134
17-OHP: Part B, Visit 4 AUC 1500-2300h214.89 ± 364.641
SecondaryAUC Values (Pmol*h/L) for ACTH

AUC values (pmol\*h/L) for ACTH for the following reporting periods: 24 hours (2300-2300h), 2300-0700h, 0700-1500h and 1500-2300h

Time frame:
Specific time points (2300-2300h, 2300-0700h, 0700-1500h and 1500-2300h)
Reported as:
Mean · pmol*h/L
AUC Values (Pmol*h/L) for ACTH
pmol*h/LHydrocortisone Modified Release Capsules
ACTH: Part A, Days 1-2 AUC (2300-2300h)356.25 ± 415.949
ACTH: Part A, Days 1-2 AUC (2300-0700h)54.72 ± 70.267
ACTH: Part A, Days 1-2 AUC (0700-1500h)166.18 ± 206.294
ACTH: Part A, Days 1-2 AUC (1500-2300h)135.35 ± 169.002
ACTH: Part A, Days 4-5 AUC (2300-2300h)120.00 ± 121.454
ACTH: Part A, Days 4-5 AUC (2300-0700h)52.22 ± 62.067
ACTH: Part A, Days 4-5 AUC (0700-1500h)21.29 ± 19.824
ACTH: Part A, Days 4-5 AUC (1500-2300h)47.13 ± 57.145
ACTH: Part B, Visit 2 AUC (2300-2300h)125.45 ± 118.081
ACTH: Part B, Visit 2 AUC (2300-0700h)43.09 ± 46.711
ACTH: Part B, Visit 2 AUC (0700-1500h)34.14 ± 48.423
ACTH: Part B, Visit 2 AUC (1500-2300h)48.22 ± 49.078
ACTH: Part B, Visit 3 AUC (2300-2300h)154.10 ± 172.474
ACTH: Part B, Visit 3 AUC (2300-0700h)50.02 ± 57.268
ACTH: Part B, Visit 3 AUC (0700-1500h)52.46 ± 64.571
ACTH: Part B, Visit 3 AUC (1500-2300h)51.63 ± 70.735
ACTH: Part B, Visit 4 AUC (2300-2300h)252.30 ± 420.220
ACTH: Part B, Visit 4 AUC (2300-0700h)58.80 ± 107.955
ACTH: Part B, Visit 4 AUC (0700-1500h)110.58 ± 329.386
ACTH: Part B, Visit 4 AUC (1500-2300h)82.92 ± 120.287

Adverse events

Collected over Approximately 7 months. Non-serious events are listed at a 5% frequency threshold.

Adverse event summary by group
GroupDeathsSeriousOther
Hydrocortisone Modified Release Capsules—0/16 (0%)16/16 (100%)
Most frequent other events
Showing 10 of 11
Most frequent other events
EventHydrocortisone Modified Release Capsules
HeadacheNervous system disorders13/16
FatigueGeneral disorders13/16
DizzinessNervous system disorders8/16
AnaemiaBlood and lymphatic system disorders7/16
Weight increaseInvestigations7/16
Appetite decreaseMetabolism and nutrition disorders7/16
Appetite increaseMetabolism and nutrition disorders6/16
ArthralgiaMusculoskeletal and connective tissue disorders5/16
InsomniaPsychiatric disorders5/16
AcneSkin and subcutaneous tissue disorders5/16

Baseline characteristics

All treated subjects

Age, Continuous
Age, Continuous(years)Hydrocortisone Modified Release Capsules
Mean28.7 ± 12.97
Sex: Female, Male
Sex: Female, Male(Participants)Hydrocortisone Modified Release Capsules
Female8
Male8
Race (NIH/OMB)
Race (NIH/OMB)(Participants)Hydrocortisone Modified Release Capsules
American Indian or Alaska Native0
Asian0
Native Hawaiian or Other Pacific Islander0
Black or African American1
White13
More than one race1
Unknown or Not Reported1
Region of Enrollment
Region of Enrollment(participants)Hydrocortisone Modified Release Capsules
United States16
07

Study locations

1 site
  • National Institutes of Health Clinical Center
    Bethesda, Maryland 20892-1932, United States
08

References and documents

Publications

  • Mallappa A, Sinaii N, Kumar P, Whitaker MJ, Daley LA, Digweed D, Eckland DJ, Van Ryzin C, Nieman LK, Arlt W, Ross RJ, Merke DP. A phase 2 study of Chronocort, a modified-release formulation of hydrocortisone, in the treatment of adults with classic congenital adrenal hyperplasia. J Clin Endocrinol Metab. 2015 Mar;100(3):1137-45. doi: 10.1210/jc.2014-3809. Epub 2014 Dec 11. PubMed 25494662 ↗

Individual participant data

Plan to share: No

09

Registry details

Key details

Study ID
NCT01735617
Lead sponsor
Neurocrine UK Limited
Collaborators
National Institutes of Health (NIH)
Responsible party
Sponsor
First posted
Nov 28, 2012
Start date
Dec 2012
Primary completion
Dec 2013
Completion
Dec 2013
Results posted
May 17, 2017
Last update
May 17, 2017

Study contacts

Deborah P Merke, BS, MS, MD
principal investigator · National Institutes of Health Clinical Center (CC)

Oversight

Data monitoring committee
No
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