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A Clinical Trial of KT07 Capsule in the U.S.A

Sponsor
Yiling Pharmaceutical Inc. (Industry)
Overall Status
Completed
CT.gov ID
NCT02867358
Collaborator
(none)
391
Enrollment
81
Locations
3
Arms
46.9
Actual Duration (Months)
4.8
Patients Per Site
0.1
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

The purpose of this study is to investigate clinical efficacy of KT07 capsule in alleviation of fever and other symptoms including nasal congestion, sore throat, cough, aches and pains, fatigue, headache, chills or sweats in subjects with acute uncomplicated influenza.

Condition or Disease Intervention/Treatment Phase
  • Drug: KT07 Capsule
  • Other: Placebo
 Phase 2

Study Design

Study Type:
Interventional
Actual Enrollment :
391 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
Double (Participant, Investigator)
Primary Purpose:
Treatment
Official Title:
A Multi-center, Randomized, Double-blind, and Placebo-controlled Phase II Clinical Study to Investigate the Safety and Efficacy of Two Doses of KT07 Compared to Placebo in Subjects With Acute Uncomplicated Influenza
Actual Study Start Date :
Sep 1, 2016
Actual Primary Completion Date :
Jul 31, 2020
Actual Study Completion Date :
Jul 31, 2020

Arms and Interventions

Arm Intervention/Treatment
Active Comparator: High dose of KT07 capsule

It will assess about 140 subjects with influenza at high dose KT07 (6 capsules each time, bid).

Drug: KT07 Capsule
Other Names:
  • Lianhua Qingwen Capsule

    		•
    Active Comparator: Low dose of KT07 capsule

    It will assess about 140 subjects with influenza at low dose KT07 (4 capsules of KT07 + 2 capsules of placebo each time, bid).

    Drug: KT07 Capsule
    Other Names:
  • Lianhua Qingwen Capsule

    • Other: Placebo
    Placebo Comparator: Placebo

    It will assess 140 subjects with influenza using 6 capsules of placebo each time, bid as control.

    Other: Placebo

    Outcome Measures

    Primary Outcome Measures

    1. To investigate the improvement in reducing the duration of illness compared to placebo. [Up to 19 days]

      Duration of illness is defined as: the length of time to alleviation of all symptoms. The duration of alleviation is calculated from time 0 (first administration of study medication) to the time at which symptom is alleviated.

    Secondary Outcome Measures

    1. The reduction in duration of alleviation of individual symptom [Up to 19 days]

      From time zero to the time at which the symptom is less than or equal to mild and stable for at least 24 hours

    2. Quality of life assessment [Up to 19 days]

      Based on the self-assessment questionnaire

    Other Outcome Measures

    1. Influenza viral shedding from baseline to Day 3 and Day 6 post treatment initiation during KT07 treatment [Day 1 & 3 & 6]

      Reduction in viral shedding; Influenza viral AUC

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years to 65 Years
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No

    Inclusion Criteria

    1. Subjects with acute uncomplicated influenza with oral temperature ≥ 37.8 ℃ (100.04 °F); plus at least one respiratory symptom (nasal congestion, sore throat, cough); and at least one constitutional symptom (aches or pains, fatigue, headache, chills or sweats). If antipyretics were taken, may wait at least 4 hours after dosing to determine if a qualifying temperature is observed.

    2. Subjects with RIDT confirmed influenza infection.

    3. Onset of symptoms less than 48 hours before Visit 1 (Screening; study drug administration visit). The onset of symptoms is defined as either:

    • Time of the first increase in body temperature to ≥ 37.8 ℃ (100.04 °F); or

    • Time when the subject experiences at least one general or respiratory symptom.

    1. Age 18 to 65 years old.

    2. Subjects who are able to understand and willing to sign the informed consent form (ICF).

    3. All female subjects of child-bearing potential must have a negative urine pregnancy test result. All female subjects of child-bearing potential and male subjects and their spouse/partner must agree to use a medically acceptable method of contraception (e.g., abstinence, an intrauterine device, a double barrier method such as condom + spermicide or condom + diaphragm with spermicide, a contraceptive implant, an oral contraceptive or have a vasectomized partner with confirmed azoospermia) throughout the entire study period, and for 30 days for females and 90 days for males after study drug discontinuation.

    Exclusion Criteria

    1. Subjects with severe influenza virus infection requiring inpatient treatment.

    2. Subjects with concurrent infections requiring systemic antimicrobial and/or antiviral therapy at the time of screening.

    3. Subjects who have any of the following documented conditions: uncontrolled hypertension (systolic blood pressure > 140 mm Hg or diastolic blood pressure > 90 mm Hg), diabetes, asthma (any current or recent, not childhood if resolved), COPD (any), cardiac, hepatic, renal (including eGFR<60) and hematopoietic disorders, bleeding tendency or hemorrhagic disease, neurological system disease, compromised immune system (including patients receiving immunosuppressant therapy, or those with cancer within the past 5 years or human immunodeficiency virus [HIV] infection), endocrine disorders (including thyroid disorders).

    4. Subjects with anatomical nasal obstruction or gross anatomical abnormalities. For example, nasal polyps or significant nasal septal deviation.

    5. Clinically obese subjects with BMI≥40.

    6. Subjects with recent history (within 1 year) of alcoholism or substance abuse.

    7. Received influenza vaccine within 21 days.

    8. Participation in other clinical trial within 1 month, or during the study.

    9. Pregnant or breast-feeding female subjects

    10. Allergy or known allergy to components of study medication.

    11. Subjects who took a monoamine oxidase inhibitor (MAOI) within 2 weeks prior to enrollment.

    12. Previous history of difficulty swallowing capsules.

    13. Any other associated disease or condition which, in the opinion of the investigator, might restrict or impede participation in the study or affect the study results.

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Central Alabama Research Birmingham Alabama United States 35209
    2 Parkway Medical Center, LLC Birmingham Alabama United States 35215
    3 Cahaba Research, Inc. Birmingham Alabama United States 35242
    4 David Wever Pelham Alabama United States 35124
    5 Alliane Urgent Care Tolleson Arizona United States 85353
    6 Orange County Research Institute Anaheim California United States 92801
    7 Hope Clinical Research, Inc. Canoga Park California United States 91303
    8 Core Health Care Group Cerritos California United States 90703
    9 Aviva Research Escondido California United States 90205
    10 Lalla-Reddy Medical Corp. Fountain Valley California United States 92708
    11 Research Center of Fresno, Inc. Fresno California United States 93702
    12 Ark Clinical Research Long Beach California United States 90806
    13 Long Beach Clinical Trials Services, Inc Long Beach California United States 90806
    14 Downtown L.A. Research Center, Inc. Los Angeles California United States 90017
    15 IMD Medical Group Los Angeles California United States 90020
    16 Facey Medical Foundation Mission Hills California United States 91345
    17 MD Strategies Research Centers San Diego California United States 92119
    18 Empire Clinical Research Upland California United States 91786
    19 Cherry Creek Family Practice, PLLC Denver Colorado United States 80246
    20 Urgent Care-Denver Denver Colorado United States 80246
    21 Clinical Research Consulting Milford Connecticut United States 06460
    22 Comprehensive Psychiatric Center Norwich Connecticut United States 06360
    23 Doral Medical Research Doral Florida United States 33166
    24 Sweet Hope Research Specialty, Inc Miami Lakes Florida United States 33016
    25 Finlay Medical Research Corp. Miami Florida United States 33126
    26 Panamerican Health Center, Inc. Miami Florida United States 33126
    27 AppleMed Reseach, Inc. Miami Florida United States 33155
    28 Research Institute of South Florida, Inc. Miami Florida United States 33173
    29 Florida Research Center, Inc. Miami Florida United States 33174
    30 Sunrise Medical Research Tamarac Florida United States 33351
    31 Sunrise Medical Research West Palm Beach Florida United States 33406
    32 Southeast Clinical Research Williston Florida United States 32696
    33 Invocare (Savannah GA location) Rincon Georgia United States 31326
    34 Infinite Clinical Trials Riverdale Georgia United States 30274
    35 The Blackfoot Medical Center - Blackfoot Blackfoot Idaho United States 83221
    36 Buynak Clinical Research, P.C. Valparaiso Indiana United States 46383
    37 Horizon Research Group of Opelousas, LLC Eunice Louisiana United States 70535
    38 Centex Studies, Inc Lake Charles Louisiana United States 70601
    39 MedPharmics, LLC Metairie Louisiana United States 70006
    40 Centennial Medical Group Elkridge Maryland United States 21075
    41 MD Medical Research Oxon Hill Maryland United States 20745
    42 Romedica LLC Rochester Michigan United States 48307
    43 Olive Branch Family Medical Center Olive Branch Mississippi United States 38654
    44 Mercury Street Medical Group, PLLC Butte Montana United States 59701
    45 Red Rock Clinical Research, LLC Las Vegas Nevada United States 89146
    46 Hassman Research Institute Berlin New Jersey United States 08009
    47 AccuMed Research Associates Garden City New York United States 11530
    48 New York Clinical Trials Manhattan New York United States 10018
    49 Carolina Research Center, Inc Shelby North Carolina United States 28150
    50 Ardmore Family Practice Winston-Salem North Carolina United States 27103
    51 New Horizons Clinical Research Cincinnati Ohio United States 45242
    52 META Medical Research Institute, LLC Dayton Ohio United States 45432
    53 Medical Research International Oklahoma City Oklahoma United States 73109
    54 Detweiler Family Medicine Lansdale Pennsylvania United States 19446
    55 Frontier Clinical Research, LLC Scottdale Pennsylvania United States 15683
    56 Frontier Clinical Research, LLC Smithfield Pennsylvania United States 15478
    57 American Family Care Urgent Care Chattanooga Tennessee United States 37421
    58 Clinical Research Solutions, LLC Franklin Tennessee United States 37067
    59 Clinical Research Solutions, LLC Jackson Tennessee United States 38305
    60 Clinical Research Solutions, LLC Nashville Tennessee United States 37211
    61 Clinical Research Solutions, LLC Smyrna Tennessee United States 37167
    62 Clinical Research Solutions, LLC Spring Hill Tennessee United States 37174
    63 Premier Family Physicians Austin Texas United States 78735
    64 Pioneer Research Solutions Beaumont Texas United States 77702
    65 Family Medicine Associates of Texas Carrollton Texas United States 75010
    66 Corpus Christi Family Wellness Corpus Christi Texas United States 78414
    67 Northwest Med Care Cypress Texas United States 77429
    68 City Doc Urgent Care Dallas Texas United States 75230
    69 Centex Studies, Inc. Houston Texas United States 77058
    70 Centex Studies, Inc. McAllen Texas United States 78504
    71 Village Health Partners Plano Texas United States 75024
    72 Quaity Assurance Research Center San Antonio Texas United States 78207
    73 Bandera Family Health Clinic San Antonio Texas United States 78249
    74 Wade Family Medicine Bountiful Utah United States 84010
    75 J. Lewis Research, Inc./ Foothill Family Clinic Draper Draper Utah United States 84020
    76 Chrysalis Clinical Research Saint George Utah United States 84790
    77 J. Lewis Research, Inc. / Foothill Family Clinic Salt Lake City Utah United States 84109
    78 J. Lewis Research, Inc. / Foothill Family Clinic South Salt Lake City Utah United States 84121
    79 J. Lewis Research, Inc./ FirstMed East Salt Lake City Utah United States 84121
    80 CopperView Medical Center South Jordan Utah United States 84095
    81 Clinical Research Partners Richmond Virginia United States 23220

    Sponsors and Collaborators

    • Yiling Pharmaceutical Inc.

    Investigators

    • Study Director: Xuedong Gao, MD, Yiling Pharmaceutical Inc.

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Yiling Pharmaceutical Inc.
    ClinicalTrials.gov Identifier:
    NCT02867358
    Other Study ID Numbers:
    • KT07-US-01
    First Posted:
    Aug 15, 2016
    Last Update Posted:
    Aug 31, 2020
    Last Verified:
    Aug 1, 2020
    Individual Participant Data (IPD) Sharing Statement:
    No
    Plan to Share IPD:
    No
    Studies a U.S. FDA-regulated Drug Product:
    Yes
    Studies a U.S. FDA-regulated Device Product:
    No
    Keywords provided by Yiling Pharmaceutical Inc.
    acute uncomplicated influenza
    Additional relevant MeSH terms:
    Influenza, Human

    Study Results

    No Results Posted as of Aug 31, 2020