Transcript product presentation

An Open Label, Multicenter, Controlled Clinical Trial to Evaluate Efficacy and
Safety of DNT -53 in Patients with Low Platelet Count
Protocol No: ICBio/CR/OMP/0413/23
Version No: 01 Dated 16-APR-2013
Date of Final report
25-NOV-2013
72 Subjects
Group A-Alcoholic & Spleen Disorders - 12 Subjects
Group B- Vitamin B12 Deficiency - 12 Subjects
Number of Subjects
Group C- Malaria-12 Subjects
Group D-Viral Infections-12 Subjects
Group E- Drug Induced-12 Subjects
Group F- Bacterial Infections-12 Subjects
Primary objectives:

To evaluate the
efficacy of DNT-53 for treating Low
Platelet Count
Objectives
Secondary objectives:

To evaluate the safety of DNT-53 in subjects with Low
Platelet Count
Inclusion Criteria:
•Patients with the age group of 18 to 60 Years
•Willing to Sign on informed consent accordance with GCP and local legislation
•Patients with low Platelet count (Lower Limit- Greater than or equal to 80,000 per micro liter).
•Patient suffering from severe infectious disease in which the platelet count is generally lower.
•Patient suffering with diseases like Malaria, Vitamin B12 (or) folate deficiency, certain viral &
bacterial infections, in which the platelet count is below normal range.
Exclusion Criteria:
•Patient not willing to comply with the study procedure.
•Patients having the platelet count less than 80,000 per micro liter.
•Other serious medical illness likely to interfere with study participation
•Significant psychiatric illness, senility, dementia or substance abuse
•Drug abuse within the 3 months prior to informed consent that would interfere with trial participation
•Participation in another trial within 3 months prior to informed consent
•Dehydration by clinical judgment of the investigator, Pregnant or Lactating women
•Any contraindication to blood sampling.
•Severe reduction in kidney function OR removal of a kidney OR kidney transplant.
•Severe asthma that is poorly controlled with medication, HIV Positive serology.
•Certain medications that may interfere with the study medication (these will be identified by the
study Investigator).
Number of Subjects Enrolled according to group wise
Alcohol &
Spleen Disorder
(Group A)
Vitamin B12
Deficiency
(Group B)
Malarial
(Group C)
Viral
Infections
(Group D)
Drug
Induced
(Group E)
Bacterial
Infections
(Group F)
12
12
12
12
12
12
Demographics of the Study Patients
Gender
Male
Female
Age (years) n
Mean
Min
Max
Height (m) n
Mean
Min
Max
Weight (kg) n
Mean
Min
Max
BMI
n
(kg/m2)
Mean
Min
Max
45
27
72
37.04
18
60
72
168.13
145.00
185.00
72
63.28
40.00
86.00
72
22.37
16.20
28.30
RESULTS
Totally 72 subjects were enrolled in to the study and all 72 subjects completed the
study the efficacy was analyzed by considering the screening, Day 11 and Day 56
platelet count.
The overall Mean Platelet count of 72 subjects (n=72)
Mean platelet count on Screening (day-0), day 11 and Day 56 was found to be 127131.94,
207708.33, 270680.56 Lakhs/cumm. However statistical increase of 38.79% and 53.03% in Platelet
Count was found on day 11 and Day 56 when compared from Screening Platelet count.
Day 11 Mean change
Screening
(Lakhs/cu (Lakhs/cumm
(Lakhs/cumm)
mm)
)
Mean
Platelet
Count
127131.94
207708.33
80576.39
Percentage
Increased
38.79%
Screening
Day 56
Mean change
(Lakhs/cu
(Lakhs/cumm) (Lakhs/cumm)
mm)
Mean
Platelet 127131.94
Count
270680.56
143548.61
Percentage
Increased
53.03%
Mean Platelet Count, Mean Change and Mean percentage change
group wise
Mean Platelet count of Alcoholic & Spleen Disorders Group Subjects (n=12)
In this Group total 12 subjects were completed the study and Mean platelet count on Screening
(day-0), Day 11 and Day 56 were found to be 127416.67, 206916.67, 258250 Lakhs/cumm.
However statistical increase of 38.42 % and 50.66% in Platelet Count were found on day 11 and
Day 56 when compared from Screening Platelet count.
Screening Day 11 Mean change
Percentage
(Lakhs/cu (Lakhs/cum (Lakhs/cumm
Increased
mm)
m)
)
Mean
Platelet 127416.67 206916.67
Count
79500
38.42 %
Screening
Day 56
Mean change
(Lakhs/cu (Lakhs/cumm
(Lakhs/cumm)
mm)
)
Mean
Platelet 127416.67
Count
258250
130833.33
Percentage
Increased
50.66 %
Mean Platelet count of Vitamin B12 Deficiency Group Subjects (n=12)
In this Group total 12 subjects were completed the study and Mean platelet count on Screening (day0), Day 11 and Day 56 were found to be 126833.33, 195666.7, 270916.67 Lakhs/cumm. However
statistical increase of 35.18 % and 53.18% in Platelet Count were found on day 11 and Day 56 when
compared from Screening Platelet count.
Screening Day 11 Mean change
Percentage
(Lakhs/cu (Lakhs/cu (Lakhs/cumm
Increased
mm)
mm)
)
Mean
Platelet 126833.33 195666.7
Count
68833.33
35.18 %
Screening Day 56 Mean change
Percentage
(Lakhs/cu (Lakhs/cum (Lakhs/cum
Increased
mm)
m)
m)
Mean
Platelet 126833.33 270916.67
Count
144083.33
53.18 %
Mean Platelet count of Viral Infection Group Subjects (n=12)
In this Group total 12 subjects were completed the study and Mean platelet count on Screening
(day-0), Day 11 and Day 56 were found to be 129666.7, 223333.33, 246833.33 Lakhs/cumm.
However statistical increase of 41.94 % and 4747% in Platelet Count were found on day 11 and Day
56 when compared from Screening Platelet count.
Screening
Day 11
Mean change
(Lakhs/cum (Lakhs/cumm
(Lakhs/cumm)
m)
)
Mean
Platelet 129666.7
Count
223333.33
93666.63
Screening
Day 56
Mean change
(Lakhs/cum (Lakhs/cumm
(Lakhs/cumm)
m)
)
Percentage
Increased
41.94 %
Mean
Platelet
Count
129666.7
246833.33
117166.63
Percentage
Increased
47.47 %
Mean Platelet count of Drug Induced Group Subjects (n=12)
In this Group total 12 subjects were completed the study and Mean platelet count on Screening (day0), Day 11 and Day 56 were found to be 132416.67, 220666.67, 257750 Lakhs/cumm. However
statistical increase of 40.0% and 48.63% in Platelet Count were found on day 11 and Day 56 when
compared from Screening Platelet count.
Screening
Day 11
Mean change
(Lakhs/cum (Lakhs/cum
(Lakhs/cumm)
m)
m)
Mean
Platelet 132416.67 220666.67
Count
88250
Percentage
Increased
40.0 %
Screening
Day 56
Mean change Percentage
(Lakhs/cum (Lakhs/cum
(Lakhs/cumm) Increased
m)
m)
Mean
Platelet 132416.67
Count
257750
125333.33
48.63%
Mean Platelet count of Malarial Group Subjects (n=12)
In this Group total 12 subjects were completed the study and Mean platelet count on Screening
(day-0), Day 11 and Day 56 were found to be 125791.67, 189333.33, 293166.67 Lakhs/cumm.
However statistical increase of 33.56 % and 57.09 % in Platelet Count were found on day 11 and
Day 56 when compared from Screening Platelet count.
Screening
Day 11 Mean change
Percentage
(Lakhs/cu (Lakhs/cum (Lakhs/cumm
Increased
mm)
m)
)
Mean
Platelet 125791.67 189333.33
Count
63541.67
33.56 %
Mean
Screening Day 56
change
Percentage
(Lakhs/cu (Lakhs/cum
(Lakhs/cum Increased
mm)
m)
m)
Mean
Platele
125791.67 293166.67
t
Count
167375
57.09 %
Mean Platelet count of Bacterial Infection Group Subjects (n=12)
In this Group total 12 subjects were completed the study and Mean platelet count on Screening
(day-0), Day 11 and Day 56 were found to be 120666.67, 210333.33, 297166.67 Lakhs/cumm.
However statistical increase of 42.63 % and 59.39 % in Platelet Count were found on day 11 and
Day 56 when compared from Screening Platelet count.
Screening
Day 11
Mean change Percentage
(Lakhs/cum (Lakhs/cum
(Lakhs/cumm) Increased
m)
m)
Mean
Platelet 120666.67 210333.33
Count
89666.67
42.63 %
Screening
Day 56
Mean change
(Lakhs/cum (Lakhs/cum
(Lakhs/cumm)
m)
m)
Mean
Platelet 120666.67 297166.67
Count
176500
Percentage
Increased
59.39 %
DISCUSSION & CONCLUSION
All 72 enrolled subjects were advised to take study drug as protocol prescribed and
they were advised to attend every alternate day visits to site. The data has been
collected and analyzed from 72 subjects who have completed all study visits and
it was found that there was significant increase in platelet count irrespective of
groups.
We analyzed group wise platelet count and found that the platelet count was
significantly increased in all the subjects in all mentioned groups.
There was no drop out subjects during the study.
From the data obtained, it was found that the investigational product DNT-53 was
showing significant percentage increase in Platelet count throughout the study
duration when compared to screening platelet level in all enrolled subjects, which
was considered as an important parameter in this study.